Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2025-12-27 @ 10:19 PM
Study NCT ID:
NCT01681095
Status:
COMPLETED
Last Update Posted:
2019-08-06
First Post:
2012-08-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Custodiol-HTK (Histidine-tryptophan-ketoglutarate) Solution as a Cardioplegic Agent
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C039984', 'term': 'Bretschneider cardioplegic solution'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'marc.sakwa@beaumont.org', 'phone': '248/898-0123', 'title': 'Marc P. Sakwa, M.D.', 'organization': 'William Beaumont Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Adverse events (not serious adverse events) are listed only for events occurring with greater than 5% frequency in at least one of the groups.'}}, 'adverseEventsModule': {'timeFrame': 'AEs were evaluated from time of consent to 4 days after surgery.', 'description': 'An assessment of medical records and case report forms were examined for AEs or SAEs. Reports were reviewed by the PI for accuracy and relation to study intervention.', 'eventGroups': [{'id': 'EG000', 'title': 'Cardioplegia: Custodiol HTK Solution', 'description': 'Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.\n\nCustodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C.', 'otherNumAtRisk': 55, 'otherNumAffected': 25, 'seriousNumAtRisk': 55, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Cold Blood Cardioplegia', 'description': 'Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.\n\nAfter cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional \\> 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C.', 'otherNumAtRisk': 55, 'otherNumAffected': 34, 'seriousNumAtRisk': 55, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'A-Fib or fA-Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No source vocabulary'}, {'term': 'Trombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No source vocabulary'}, {'term': 'Heart Block (complete, 1st AV, 2 AV, 3 AV)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No source vocabulary'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No source vocabulary'}, {'term': 'Bleeding (any)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No source vocabulary'}, {'term': 'Acute blood loss anemina/any anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No source vocabulary'}, {'term': 'Junctional Rhythm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No source vocabulary'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No source vocabulary'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No source vocabulary'}, {'term': 'Acute Kidney Failure/Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No source vocabulary'}], 'seriousEvents': [{'term': 'Profuse bleeding', 'notes': 'Approximately 2 hours post-op the subject returned to the OR for re-exploration, finding right ventricular tear. This event was unexpected, and no action was taken with repect to the study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No source vocabulary'}, {'term': 'Acute Respiratory failure', 'notes': 'Dx 2 days post-op requiring reintubation on 12/19/2012, resolving 1/17/2013, considered an SAE due to prolonged hospitalization, impairment of body structure or body function (Trach on 12/23/2012), unexpected, possibly related to underlying disease.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No source vocabulary'}, {'term': 'Acute chest pain, shortness of breath', 'notes': 'ER via EMS, L sided chest pain and SOB. Cardiac eval performed. ECG, chest x-ray and labs normal. Admitted for evaluation; the condition resolved. SAE due to hospitalization; unexpected, not related to drug, probably related to underlying disease.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No source vocabulary'}, {'term': 'Atrial Fib with rapid ventricular response', 'notes': 'PO day 8, EC visit for weakness, ECG demonstrates A-fib w/RVR. Remained in observation, sx resolving within24 hours.SAE due to hospitalization, possibly r/t cardioplegia and possibly underlying disease, unexpected event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No source vocabulary'}, {'term': 'SOB, peripheral edema, mouth pain 16 days post-op', 'notes': 'Subject to ER via EMS. Con-med: Levaquin for pneumonia. Con-med change after evaluation. Resolving after 14days. Possibly r/t study compound, and an unexpected event.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No source vocabulary'}, {'term': 'Mediastinal bleed', 'notes': 'Mediastinal bleed repaired day of surgery and considered resolved. Not related to treatment, possible related to underlying disease and unexpected.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No source vocabulary'}, {'term': 'Hospitalization', 'notes': 'Direct admit from follow-up appt. Fatigue, R groin incision weeping, Atrial flutter w/RVR. Con-med change for incision. Cardioversion. SAE for hospitalization. Resolved and doubtful related to study compound, possible underlying disease.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No source vocabulary'}, {'term': 'CVA', 'notes': '1 day post-op, head CT for stroke like sx showing acute cerebral infarct. Con-med changes for L Carotid 30-50% narrowing. Not related to study compound, not related to underlying disease, unexpected. Resolved with sequelae within 9 days.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No source vocabulary'}, {'term': 'Community acquired pneumonia', 'notes': 'ER presentation with hospital admission. Chest x-ray confirming dx. Con-med change. SAE due to hospitalization, not related to study compound, possibly related to underlying disease, unexpected event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No source vocabulary'}, {'term': 'Femoral occlusion', 'notes': 'c/o leg pain, decreased peripheral pulse. 8 days PO performed femoral endarterectomy. Not related to study compound, not related to underlying disease and an unexpected event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No source vocabulary'}, {'term': 'Respiratory failure', 'notes': 'Requiring vent support due to not able to extubate. SAE d/t prolonged hospitalization, not related to study compound, related to underlying disease, an unexpected event.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No source vocabulary'}, {'term': 'Emergent Coronary Bypass', 'notes': 'Hypoxia, hypotension following MVR. Treated 2 vessels via full sternotomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No source vocabulary'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Creatine Phosphokinase-MB Isoenzyme (CK-MB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardioplegia: Custodiol HTK Solution', 'description': 'Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.\n\nCustodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C.'}, {'id': 'OG001', 'title': 'Cold Blood Cardioplegia', 'description': 'Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.\n\nAfter cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional \\> 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000', 'lowerLimit': '12.5', 'upperLimit': '24'}, {'value': '22.2', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '51'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 7 hours post surgery', 'description': 'Creatine phosphokinase MB isoenzyme (CK-MB) difference from baseline 7 hours post surgery', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients for which both baseline and 7 hours post surgery values were available'}, {'type': 'PRIMARY', 'title': 'Change in Troponin I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardioplegia: Custodiol HTK Solution', 'description': 'Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.\n\nCustodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C.'}, {'id': 'OG001', 'title': 'Cold Blood Cardioplegia', 'description': 'Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.\n\nAfter cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional \\> 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.65', 'groupId': 'OG000', 'lowerLimit': '5.47', 'upperLimit': '16.00'}, {'value': '10.15', 'groupId': 'OG001', 'lowerLimit': '6.04', 'upperLimit': '19.97'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 7 hours post surgery', 'description': 'Troponin I values, difference from baseline 7 hours post surgery', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Changes in Left Ventricular (LV) Ejection Fraction (EF) by Transthoracic Echocardiogram (TTE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardioplegia: Custodiol HTK Solution', 'description': 'Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.\n\nCustodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C.'}, {'id': 'OG001', 'title': 'Cold Blood Cardioplegia', 'description': 'Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.\n\nAfter cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional \\> 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.06', 'spread': '11', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 hours post surgery', 'description': 'LV ejection fraction by TTE, difference from baseline at 24 hours post surgery', 'unitOfMeasure': '% LV volume', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'patients for whom both preoperative and 24 hour LV ejection fractions were obtained'}, {'type': 'SECONDARY', 'title': 'Cardiac Dysrhythmias', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardioplegia: Custodiol HTK Solution', 'description': 'Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.\n\nCustodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C.'}, {'id': 'OG001', 'title': 'Cold Blood Cardioplegia', 'description': 'Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.\n\nAfter cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional \\> 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 36 hrs post surgery', 'description': 'Number of participants with new or worsening of cardiac dysrhythmias', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'All Cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardioplegia: Custodiol HTK Solution', 'description': 'Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.\n\nCustodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C.'}, {'id': 'OG001', 'title': 'Cold Blood Cardioplegia', 'description': 'Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.\n\nAfter cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional \\> 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days post procedure', 'description': 'Number of participants with all-cause mortality AS reported in the Society of Thoracic Surgeons (STS) database after 30 days postoperative', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cardiovascular Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardioplegia: Custodiol HTK Solution', 'description': 'Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.\n\nCustodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C.'}, {'id': 'OG001', 'title': 'Cold Blood Cardioplegia', 'description': 'Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.\n\nAfter cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional \\> 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days post procedure', 'description': 'Number of participants with cardiovascular-related mortality AS reported in the Society of Thoracic Surgeons (STS) database after 30 days postoperative', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time on Mechanically Assisted Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardioplegia: Custodiol HTK Solution', 'description': 'Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.\n\nCustodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C.'}, {'id': 'OG001', 'title': 'Cold Blood Cardioplegia', 'description': 'Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.\n\nAfter cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional \\> 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '9.1', 'upperLimit': '13.9'}, {'value': '11.4', 'groupId': 'OG001', 'lowerLimit': '3.9', 'upperLimit': '527'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 36 hours post procedure', 'description': 'time in hours from intubation to extubation, with intervening transport to the cardiac critical care unit.', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Vasopressor / Inotropic Agent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardioplegia: Custodiol HTK Solution', 'description': 'Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.\n\nCustodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C.'}, {'id': 'OG001', 'title': 'Cold Blood Cardioplegia', 'description': 'Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.\n\nAfter cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional \\> 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '340', 'groupId': 'OG000', 'lowerLimit': '115', 'upperLimit': '636'}, {'value': '582', 'groupId': 'OG001', 'lowerLimit': '154', 'upperLimit': '1182'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 36 hours post procedure', 'description': 'Total time in minutes on any vasopressor or inotropic agent, including norepinephrine, epinephrine, vasopressin, milrinone, dobutamine, dopamine and/or neo-synephrine', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients not receiving any vasopressors are excluded from this analysis'}, {'type': 'SECONDARY', 'title': 'Postoperative Inotropic Infusion >20 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardioplegia: Custodiol HTK Solution', 'description': 'Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.\n\nCustodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C.'}, {'id': 'OG001', 'title': 'Cold Blood Cardioplegia', 'description': 'Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.\n\nAfter cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional \\> 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'during operative procedure', 'description': 'Number of patients receiving vasopressor or inotropic infusion for greater than 20 minutes in the operating room, including norepinephrine, epinephrine, vasopressin, milrinone, dobutamine, dopamine and/or neo-synephrine.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intensive Care Unit (ICU) Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardioplegia: Custodiol HTK Solution', 'description': 'Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.\n\nCustodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C.'}, {'id': 'OG001', 'title': 'Cold Blood Cardioplegia', 'description': 'Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.\n\nAfter cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional \\> 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 100 days after admission', 'description': 'Duration of stay in ICU, from ICU admission to ICU discharge', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Myocardial Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardioplegia: Custodiol HTK Solution', 'description': 'Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.\n\nCustodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C.'}, {'id': 'OG001', 'title': 'Cold Blood Cardioplegia', 'description': 'Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.\n\nAfter cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional \\> 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 36 hours post procedure', 'description': 'Number or participants fulfilling at least two of the following 3 criteria: (1) CK-MB of 100 ug/L or more and/or troponin-I of 3.0 ug/L or more, (2) appearance of new postoperative Q waves on the EKG of more than 0.03 seconds, and (3) a new hypokinetic or akinetic area in the left or right ventricle by echocardiography.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Biochemical Marker - Creatine Kinase MB Isoenzyme (CK-MB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardioplegia: Custodiol HTK Solution', 'description': 'Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.\n\nCustodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C.'}, {'id': 'OG001', 'title': 'Cold Blood Cardioplegia', 'description': 'Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.\n\nAfter cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional \\> 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-operative', 'description': 'CK-MB measured pre-operatively', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients for whom preoperative CK-MB levels were available were analyzed'}, {'type': 'SECONDARY', 'title': 'Biochemical Marker - Creatine Kinase MB Isoenzyme (CK-MB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardioplegia: Custodiol HTK Solution', 'description': 'Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.\n\nCustodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C.'}, {'id': 'OG001', 'title': 'Cold Blood Cardioplegia', 'description': 'Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.\n\nAfter cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional \\> 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'spread': '14', 'groupId': 'OG000'}, {'value': '24', 'spread': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours post procedure', 'description': 'CK-MB measured 24 hours post-operatively', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients for whom 24 hour CK-MB values were available were analyzed'}, {'type': 'SECONDARY', 'title': 'Biochemical Marker - Creatine Kinase MB Isoenzyme (CK-MB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardioplegia: Custodiol HTK Solution', 'description': 'Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.\n\nCustodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C.'}, {'id': 'OG001', 'title': 'Cold Blood Cardioplegia', 'description': 'Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.\n\nAfter cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional \\> 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '7.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours post procedure', 'description': 'CK-MB measured 48 hours post-operatively', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients for whom 48 hour CK-MB values are available are included in analysis'}, {'type': 'SECONDARY', 'title': 'Cardiac Marker - Troponin-I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardioplegia: Custodiol HTK Solution', 'description': 'Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.\n\nCustodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C.'}, {'id': 'OG001', 'title': 'Cold Blood Cardioplegia', 'description': 'Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.\n\nAfter cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional \\> 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '.03', 'spread': '.01', 'groupId': 'OG000'}, {'value': '.03', 'spread': '.01', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-operatively', 'description': 'Troponin-I measured pre-operatively', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients for whom preoperative Troponin-I values were available were included in analysis'}, {'type': 'SECONDARY', 'title': 'Cardiac Marker - Troponin-I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardioplegia: Custodiol HTK Solution', 'description': 'Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.\n\nCustodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C.'}, {'id': 'OG001', 'title': 'Cold Blood Cardioplegia', 'description': 'Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.\n\nAfter cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional \\> 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '8.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours post procedure', 'description': 'Troponin-I measured 24 hours post-operative', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients for whom 24-hour Troponin-I values were available were included in analysis'}, {'type': 'SECONDARY', 'title': 'Cardiac Marker - Troponin-I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardioplegia: Custodiol HTK Solution', 'description': 'Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.\n\nCustodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C.'}, {'id': 'OG001', 'title': 'Cold Blood Cardioplegia', 'description': 'Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.\n\nAfter cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional \\> 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '6.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours post procedure', 'description': 'Troponin-I measured 48 hours post-operative', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients for whom 48-hour Troponin-I values were available were included in analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cardioplegia: Custodiol HTK Solution', 'description': 'Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.\n\nCustodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C.'}, {'id': 'FG001', 'title': 'Cold Blood Cardioplegia', 'description': 'Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.\n\nAfter cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional \\> 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Cold Blood Cardioplegia', 'description': '55 participants were randomized to Standard cold blood cardioplegia. Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.\n\nAfter cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional \\> 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C.'}, {'id': 'BG001', 'title': 'Custiodiol HTK', 'description': '55 participants were randomized to Custodiol HTK. Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.\n\nCustodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70', 'spread': '11', 'groupId': 'BG000'}, {'value': '63', 'spread': '13', 'groupId': 'BG001'}, {'value': '66', 'spread': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-23', 'studyFirstSubmitDate': '2012-08-10', 'resultsFirstSubmitDate': '2016-04-26', 'studyFirstSubmitQcDate': '2012-09-04', 'lastUpdatePostDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-10', 'studyFirstPostDateStruct': {'date': '2012-09-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Creatine Phosphokinase-MB Isoenzyme (CK-MB)', 'timeFrame': 'Baseline and 7 hours post surgery', 'description': 'Creatine phosphokinase MB isoenzyme (CK-MB) difference from baseline 7 hours post surgery'}, {'measure': 'Change in Troponin I', 'timeFrame': 'Baseline and 7 hours post surgery', 'description': 'Troponin I values, difference from baseline 7 hours post surgery'}, {'measure': 'Changes in Left Ventricular (LV) Ejection Fraction (EF) by Transthoracic Echocardiogram (TTE)', 'timeFrame': 'Baseline and 24 hours post surgery', 'description': 'LV ejection fraction by TTE, difference from baseline at 24 hours post surgery'}], 'secondaryOutcomes': [{'measure': 'Cardiac Dysrhythmias', 'timeFrame': 'up to 36 hrs post surgery', 'description': 'Number of participants with new or worsening of cardiac dysrhythmias'}, {'measure': 'All Cause Mortality', 'timeFrame': '30 days post procedure', 'description': 'Number of participants with all-cause mortality AS reported in the Society of Thoracic Surgeons (STS) database after 30 days postoperative'}, {'measure': 'Cardiovascular Mortality', 'timeFrame': '30 days post procedure', 'description': 'Number of participants with cardiovascular-related mortality AS reported in the Society of Thoracic Surgeons (STS) database after 30 days postoperative'}, {'measure': 'Time on Mechanically Assisted Ventilation', 'timeFrame': 'up to 36 hours post procedure', 'description': 'time in hours from intubation to extubation, with intervening transport to the cardiac critical care unit.'}, {'measure': 'Duration of Vasopressor / Inotropic Agent', 'timeFrame': 'up to 36 hours post procedure', 'description': 'Total time in minutes on any vasopressor or inotropic agent, including norepinephrine, epinephrine, vasopressin, milrinone, dobutamine, dopamine and/or neo-synephrine'}, {'measure': 'Postoperative Inotropic Infusion >20 Minutes', 'timeFrame': 'during operative procedure', 'description': 'Number of patients receiving vasopressor or inotropic infusion for greater than 20 minutes in the operating room, including norepinephrine, epinephrine, vasopressin, milrinone, dobutamine, dopamine and/or neo-synephrine.'}, {'measure': 'Intensive Care Unit (ICU) Length of Stay', 'timeFrame': 'up to 100 days after admission', 'description': 'Duration of stay in ICU, from ICU admission to ICU discharge'}, {'measure': 'Myocardial Infarction', 'timeFrame': 'up to 36 hours post procedure', 'description': 'Number or participants fulfilling at least two of the following 3 criteria: (1) CK-MB of 100 ug/L or more and/or troponin-I of 3.0 ug/L or more, (2) appearance of new postoperative Q waves on the EKG of more than 0.03 seconds, and (3) a new hypokinetic or akinetic area in the left or right ventricle by echocardiography.'}, {'measure': 'Biochemical Marker - Creatine Kinase MB Isoenzyme (CK-MB)', 'timeFrame': 'pre-operative', 'description': 'CK-MB measured pre-operatively'}, {'measure': 'Biochemical Marker - Creatine Kinase MB Isoenzyme (CK-MB)', 'timeFrame': '24 hours post procedure', 'description': 'CK-MB measured 24 hours post-operatively'}, {'measure': 'Biochemical Marker - Creatine Kinase MB Isoenzyme (CK-MB)', 'timeFrame': '48 hours post procedure', 'description': 'CK-MB measured 48 hours post-operatively'}, {'measure': 'Cardiac Marker - Troponin-I', 'timeFrame': 'pre-operatively', 'description': 'Troponin-I measured pre-operatively'}, {'measure': 'Cardiac Marker - Troponin-I', 'timeFrame': '24 hours post procedure', 'description': 'Troponin-I measured 24 hours post-operative'}, {'measure': 'Cardiac Marker - Troponin-I', 'timeFrame': '48 hours post procedure', 'description': 'Troponin-I measured 48 hours post-operative'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Physiological Effects of Drugs', 'Cardiovascular Agents', 'Therapeutic Uses', 'Pharmacologic Actions', 'Mannitol', 'Cardiac Surgery', 'Cardioplegic Solutions', 'HTK solution', 'Myocardial protection', 'Coronary Artery Disease', 'Myocardial Ischemia', 'Coronary Disease', 'Heart Diseases'], 'conditions': ['Coronary Artery Disease', 'Myocardial Ischemia', 'Coronary Disease', 'Heart Diseases', 'Valvular Heart Disease']}, 'referencesModule': {'references': [{'pmid': '20800244', 'type': 'BACKGROUND', 'citation': 'Braathen B, Jeppsson A, Schersten H, Hagen OM, Vengen O, Rexius H, Lepore V, Tonnessen T. One single dose of histidine-tryptophan-ketoglutarate solution gives equally good myocardial protection in elective mitral valve surgery as repetitive cold blood cardioplegia: a prospective randomized study. J Thorac Cardiovasc Surg. 2011 Apr;141(4):995-1001. doi: 10.1016/j.jtcvs.2010.07.011. Epub 2010 Aug 30.'}, {'pmid': '11440787', 'type': 'BACKGROUND', 'citation': 'Careaga G, Salazar D, Tellez S, Sanchez O, Borrayo G, Arguero R. Clinical impact of histidine-ketoglutarate-tryptophan (HTK) cardioplegic solution on the perioperative period in open heart surgery patients. Arch Med Res. 2001 Jul-Aug;32(4):296-9. doi: 10.1016/s0188-4409(01)00296-x.'}, {'pmid': '8698763', 'type': 'BACKGROUND', 'citation': 'Hachida M, Ookado A, Nonoyama M, Koyanagi H. Effect of HTK solution for myocardial preservation. J Cardiovasc Surg (Torino). 1996 Jun;37(3):269-74.'}, {'pmid': '16039259', 'type': 'BACKGROUND', 'citation': 'Yang Q, He GW. Effect of cardioplegic and organ preservation solutions and their components on coronary endothelium-derived relaxing factors. Ann Thorac Surg. 2005 Aug;80(2):757-67. doi: 10.1016/j.athoracsur.2004.10.003.'}, {'pmid': '2106735', 'type': 'BACKGROUND', 'citation': 'Beyersdorf F, Krause E, Sarai K, Sieber B, Deutschlander N, Zimmer G, Mainka L, Probst S, Zegelman M, Schneider W, et al. Clinical evaluation of hypothermic ventricular fibrillation, multi-dose blood cardioplegia, and single-dose Bretschneider cardioplegia in coronary surgery. Thorac Cardiovasc Surg. 1990 Feb;38(1):20-9. doi: 10.1055/s-2007-1013985.'}, {'pmid': '15769709', 'type': 'BACKGROUND', 'citation': "Savini C, Camurri N, Castelli A, Dell'Amore A, Pacini D, Suarez SM, Grillone G, Di Bartolomeo R. Myocardial protection using HTK solution in minimally invasive mitral valve surgery. Heart Surg Forum. 2005;8(1):E25-7. doi: 10.1532/HSF98.20041145."}, {'pmid': '19660338', 'type': 'BACKGROUND', 'citation': 'Braathen B, Tonnessen T. Cold blood cardioplegia reduces the increase in cardiac enzyme levels compared with cold crystalloid cardioplegia in patients undergoing aortic valve replacement for isolated aortic stenosis. J Thorac Cardiovasc Surg. 2010 Apr;139(4):874-80. doi: 10.1016/j.jtcvs.2009.05.036. Epub 2009 Jul 26.'}, {'pmid': '10469959', 'type': 'BACKGROUND', 'citation': 'Hendrikx M, Jiang H, Gutermann H, Toelsie J, Renard D, Briers A, Pauwels JL, Mees U. Release of cardiac troponin I in antegrade crystalloid versus cold blood cardioplegia. J Thorac Cardiovasc Surg. 1999 Sep;118(3):452-9. doi: 10.1016/s0022-5223(99)70182-0.'}, {'pmid': '19628529', 'type': 'BACKGROUND', 'citation': "Aarsaether E, Stenberg TA, Jakobsen O, Busund R. Mechanoenergetic function and troponin T release following cardioplegic arrest induced by St Thomas' and histidine-tryptophan-ketoglutarate cardioplegia--an experimental comparative study in pigs. Interact Cardiovasc Thorac Surg. 2009 Oct;9(4):635-9. doi: 10.1510/icvts.2009.208231. Epub 2009 Jul 23."}, {'pmid': '3145585', 'type': 'BACKGROUND', 'citation': 'Gallandat Huet RC, Karliczek GF, van der Heide JN, Brenken U, Mooi B, van der Broeke JJ, Jenkins I, de Geus AF. Clinical effect of Bretschneider-HTK and St. Thomas cardioplegia on hemodynamic performance after bypass measured using an automatic datalogging database system. Thorac Cardiovasc Surg. 1988 Jun;36(3):151-6. doi: 10.1055/s-2007-1020064.'}, {'pmid': '16213352', 'type': 'BACKGROUND', 'citation': 'Arslan A, Sezgin A, Gultekin B, Ozkan S, Akay T, Uguz E, Tasdelen A, Aslamaci S. Low-dose histidine-tryptophan-ketoglutarate solution for myocardial protection. Transplant Proc. 2005 Sep;37(7):3219-22. doi: 10.1016/j.transproceed.2005.08.020.'}, {'pmid': '19324152', 'type': 'BACKGROUND', 'citation': 'Fannelop T, Dahle GO, Salminen PR, Moen CA, Matre K, Mongstad A, Eliassen F, Segadal L, Grong K. Multidose cold oxygenated blood is superior to a single dose of Bretschneider HTK-cardioplegia in the pig. Ann Thorac Surg. 2009 Apr;87(4):1205-13. doi: 10.1016/j.athoracsur.2009.01.041.'}, {'pmid': '3088335', 'type': 'BACKGROUND', 'citation': 'Schaper J, Scheld HH, Schmidt U, Hehrlein F. Ultrastructural study comparing the efficacy of five different methods of intraoperative myocardial protection in the human heart. J Thorac Cardiovasc Surg. 1986 Jul;92(1):47-55.'}, {'type': 'BACKGROUND', 'citation': 'Athanasuleas C., Buckberg G. Myocardial protection and cardioplegia. Cardiopulmonary Bypass. New York: CambridgeUniversity Press; 2009: p. 82.'}, {'pmid': '11250190', 'type': 'BACKGROUND', 'citation': 'Bical OM, Fromes Y, Paumier D, Gaillard D, Foiret JC, Trivin F. Does warm antegrade intermittent blood cardioplegia really protect the heart during coronary surgery? Cardiovasc Surg. 2001 Apr;9(2):188-93. doi: 10.1016/s0967-2109(00)00087-9.'}, {'pmid': '7776676', 'type': 'BACKGROUND', 'citation': 'Allen BS, Winkelmann JW, Hanafy H, Hartz RS, Bolling KS, Ham J, Feinstein S. Retrograde cardioplegia does not adequately perfuse the right ventricle. J Thorac Cardiovasc Surg. 1995 Jun;109(6):1116-24; discussion 1124-6. doi: 10.1016/S0022-5223(95)70195-8.'}, {'pmid': '9892485', 'type': 'BACKGROUND', 'citation': 'Sakata J, Morishita K, Ito T, Koshino T, Kazui T, Abe T. Comparison of clinical outcome between histidine-triptophan-ketoglutalate solution and cold blood cardioplegic solution in mitral valve replacement. J Card Surg. 1998 Jan;13(1):43-7. doi: 10.1111/j.1540-8191.1998.tb01053.x.'}, {'type': 'BACKGROUND', 'citation': 'Lee D. H., Park N. H., Keum D. Y., Choi S. Y., Lee K. S., Yoo Y. S. Comparison of Myocardial Protective Effect between the Cold Blood Cardioplegia and Histidine-Tryptophan-Ketoglutarate Solution.Korean J Thorac Cardiovasc Surg. 2004;37(9):739-41.'}, {'type': 'BACKGROUND', 'citation': 'Kim S. , Lee Y. S. , Woo J. S. , Sung S. C. , Choi P. J. , Cho G. J., Bang J. H., Roh M. S. Histidine-tryptophan-ketoglutarate Versus Blood Cardioplegic Solutions: A Prospective, Myocardial Ultrastructural Study.Korean J Thorac Cardiovasc Surg. 2007;40(1):8-16.'}, {'type': 'BACKGROUND', 'citation': 'Choi Y. S., Bang S. O. , Chang B. C. , Lee S. , Park C. H. , Kwak Y. L. A Comparison of the Effects of Histidine-tryptophan-ketoglutarate Solution versus Cold Blood Cardioplegic Solution on Myocardial Protection in Mitral Valve Surgery.Korean J Thorac Cardiovasc Surg. 2007;40(6):399-406'}, {'pmid': '10024809', 'type': 'BACKGROUND', 'citation': 'Asano H, Kyo S, Ogiwara M, Tsunemoto M, Yokote Y, Omoto R, Koike K, Kobayashi T, Kobayashi J, Taketazu M. [Single-dose and high-volume Bretschneider cardioplegic solution for congenital heart surgery]. Kyobu Geka. 1999 Jan;52(1):82-6. Japanese.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to demonstrate that Custodiol-HTK is not inferior to cold cardioplegic solution in patients undergoing cardiovascular surgery requiring cardioplegic arrest.', 'detailedDescription': 'The objective of this study is to demonstrate that Custodiol is not inferior to cold cardioplegic solution for myocardial protection by comparing standard cold blood cardioplegia to Custodiol solution with respect to myocardial injury as measured by Creatine phosphokinase MB isoenzyme (CK-MB),troponin-I at 7 hours post surgery and changes in ejection fraction by trans-thoracic echocardiogram (TTE)or trans-esophageal echocardiogram (TEE) at 24 hours post surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing scheduled cardiac surgery requiring cardioplegic arrest with expected cross clamp time\\>45 minutes\n* Patients age 18 and older\n\nExclusion Criteria:\n\n* Pregnant women\\*\n* Urgent or emergent cases\n* Repeat cardiovascular surgical procedures\n* Patients on dialysis\n* Any known allergies to components of either cardioplegia solution \\*All women of child bearing potential must have a negative serum or urine pregnancy test.'}, 'identificationModule': {'nctId': 'NCT01681095', 'briefTitle': 'Custodiol-HTK (Histidine-tryptophan-ketoglutarate) Solution as a Cardioplegic Agent', 'organization': {'class': 'OTHER', 'fullName': 'Corewell Health East'}, 'officialTitle': 'Custodiol-HTK Solution as a Cardioplegic Agent- A Prospective Non-Inferiority Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '2012-125'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cardioplegia: Custodiol HTK Solution', 'description': 'Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.\n\nCustodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C.', 'interventionNames': ['Drug: Custodiol HTK']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cold Blood Cardioplegia', 'description': 'Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.\n\nAfter cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional \\> 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C.', 'interventionNames': ['Drug: Cold Blood Cardioplegia']}], 'interventions': [{'name': 'Custodiol HTK', 'type': 'DRUG', 'otherNames': ['Histidine-tryptophan-ketoglutarate cardioplegia solution'], 'description': 'After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 10°C.', 'armGroupLabels': ['Cardioplegia: Custodiol HTK Solution']}, {'name': 'Cold Blood Cardioplegia', 'type': 'DRUG', 'description': 'After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional \\> 200 mL was administered in an antegrade/retrograde fashion throughout the remainder of the case. The cardioplegic solution was delivered at a temperature of 4°C - 8°C.', 'armGroupLabels': ['Cold Blood Cardioplegia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}], 'overallOfficials': [{'name': 'Marc Sakwa, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beaumont Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marc Sakwa, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Essential Pharmaceuticals, LLC', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marc Sakwa, MD', 'investigatorAffiliation': 'Corewell Health East'}}}}