Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-01-28 @ 9:05 PM
Study NCT ID:
NCT02192502
Status:
COMPLETED
Last Update Posted:
2023-02-14
First Post:
2014-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Use of 6% Hydroxyethylstarch (130/0.4) in Cardiac Surgical Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006895', 'term': 'Hydroxyethyl Starch Derivatives'}, {'id': 'C485123', 'term': 'HES 130-0.4'}], 'ancestors': [{'id': 'D013213', 'term': 'Starch'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'duncana@ccf.org', 'phone': '216-538-6944', 'title': 'Dr. Andra Duncan', 'organization': 'Cleveland Clinic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'HES 130/0.4 (Voluven)', 'description': '6% HES 130/0.4 during surgery\n\nHES 130/0.4 (Voluven)', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 0, 'seriousNumAtRisk': 69, 'deathsNumAffected': 0, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'Human Albumin 5%', 'description': 'human albumin 5% during surgery\n\nhuman albumin 5%', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 0, 'seriousNumAtRisk': 72, 'deathsNumAffected': 2, 'seriousNumAffected': 12}], 'seriousEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'cardiac-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nervous disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'respiratory related event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Urine Neutrophil Gelatinase-associated Lipocalin (NGAL) [Time Frame: 24 Hours After Surgery] [Designated as Safety Issue: Yes]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HES 130/0.4 (Voluven)', 'description': '6% HES 130/0.4 during surgery\n\nHES 130/0.4 (Voluven)'}, {'id': 'OG001', 'title': 'Human Albumin 5%', 'description': 'human albumin 5% during surgery\n\nhuman albumin 5%'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '5.4'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '6.4'}]}]}, {'title': 'at 1 hour after surgery', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '68'}, {'value': '4.7', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '74'}]}]}, {'title': 'at 24 hours after surgery', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '23'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '7.1', 'upperLimit': '22'}]}]}], 'analyses': [{'pValue': '0.15', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.57', 'ciUpperLimit': '1.44', 'groupDescription': 'Assuming that NGAL values follow a log normal distribution as in previous studies with a coefficient of variation of 25%, we need 52 patients per group to have 90% power at the 0.025 significance level to be able to claim non-inferiority of HES to albumin using a non-inferiority delta of a ratio of geometric means of 1.15. After Adjusting for the interim monitoring and five potential dropouts and five pilot patients (which were not included in the analyses), we planned to enroll 140 patients', 'statisticalMethod': 'generalized linear model', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'This analysis used linear mixed model with repeated measurements with an unstructured correlation structure.', 'nonInferiorityComment': 'The non-inferiority delta of a ratio of geometric means is 1.15.'}], 'paramType': 'MEDIAN', 'timeFrame': '3 measurements in total from baseline to 24 hours after surgery: the first one is at baseline; the second one is at one hour of arrive to ICU and last one is at 24 hours after surgery', 'description': 'To assess the safety of HES 130/0.4 (Voluven) versus albumin 5% on renal function we will measure urinary concentrations of neutrophil gelatinase-associated lipocalin (NGAL), an important marker of renal function, measured at baseline (following anesthetic induction and prior to surgical incision), at one hour of arrival to intensive care unit (ICU), at 24 hours following completion of surgery.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Kidney Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HES 130/0.4 (Voluven)', 'description': '6% HES 130/0.4 during surgery\n\nHES 130/0.4 (Voluven)'}, {'id': 'OG001', 'title': 'Human Albumin 5%', 'description': 'human albumin 5% during surgery\n\nhuman albumin 5%'}], 'classes': [{'title': 'No risk', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}, {'title': 'Risk', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Injury', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Failure', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.92', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.78', 'ciLowerLimit': '0.64', 'ciUpperLimit': '12.1', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'the delta for non-inferiority is 1.15'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within first 7 postoperative days', 'description': 'Postoperative kidney dysfunction using RIFLE diagnostic criteria was also assessed. Patients were assessed for risk for kidney dysfunction (RIFLE-R), injury to the kidney (RIFLE-I), failure of kidney function (RIFLE-F) using criteria based on only peak serum creatinine concentrations within the first seven postoperative days. Due to too few events, this outcome was redefined to risk (or worse) vs. no risk for this analysis.\n\nRIFLE classification criteria is listed below:\n\nRisk (RIFLE-R) Increase in serum creatinine x 1.5 from baseline Injury (RIFLE-I) Increase in serum creatinine x 2 from baseline Failure (RIFLE-F) Increase in serum creatinine x 3 from baseline Loss (RIFLE-L) Complete loss of kidney function \\> 4 weeks End stage (RIFLE-E) End-stage kidney failure \\> 3 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postop Urine IL-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HES 130/0.4 (Voluven)', 'description': '6% HES 130/0.4 during surgery\n\nHES 130/0.4 (Voluven)'}, {'id': 'OG001', 'title': 'Human Albumin 5%', 'description': 'human albumin 5% during surgery\n\nhuman albumin 5%'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '33'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '85'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '5', 'paramValue': '0.45', 'ciLowerLimit': '0.21', 'ciUpperLimit': '0.95', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'IL-18 was log-transformed', 'nonInferiorityComment': 'the non-inferiority delta was 1.15'}], 'paramType': 'MEDIAN', 'timeFrame': 'postoperative 1 hour', 'description': 'Postop Urine IL-18 (interleukin-18) measured at 1 h of arrival to ICU', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postop Urine IL-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HES 130/0.4 (Voluven)', 'description': '6% HES 130/0.4 during surgery\n\nHES 130/0.4 (Voluven)'}, {'id': 'OG001', 'title': 'Human Albumin 5%', 'description': 'human albumin 5% during surgery\n\nhuman albumin 5%'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '37', 'upperLimit': '91'}, {'value': '53', 'groupId': 'OG001', 'lowerLimit': '29', 'upperLimit': '99'}]}]}], 'analyses': [{'pValue': '0.31', 'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.45', 'ciUpperLimit': '2.10', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'IL-18 was log-transformed', 'nonInferiorityComment': 'the delta for non-inferiority is 1.15'}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours after surgery', 'description': 'Postoperative urine IL-18 (interleukin-18) measured at 24 hours after surgery', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Kidney Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HES 130/0.4 (Voluven)', 'description': '6% HES 130/0.4 during surgery\n\nHES 130/0.4 (Voluven)'}, {'id': 'OG001', 'title': 'Human Albumin 5%', 'description': 'human albumin 5% during surgery\n\nhuman albumin 5%'}], 'classes': [{'title': 'No risk', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Risk', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Injury', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Failure', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.61', 'ciUpperLimit': '1.03', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority delta was 1.15'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within the first seven postoperative days', 'description': 'kidney injury using RIFLE criteria based on both peak creatinine levels and urine output, as recommended by Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group\n\nRIFLE classification criteria is listed below:\n\nRisk (RIFLE-R) Increase in serum creatinine x 1.5 from baseline urine output \\< 0.5 mL/kg/hr for more than 6 hrs Injury (RIFLE-I) Increase in serum creatinine x 2 from baseline urine output \\< 0.5 mL/kg/hr for more than 12 hrs Failure (RIFLE-F) Increase in serum creatinine x 3 from baseline urine output \\< 0.3 mL/kg/hr for 24 hrs or anuria for 12 hrs Loss (RIFLE-L) Complete loss of kidney function \\> 4 weeks End stage (RIFLE-E) End-stage kidney failure \\> 3 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HES 130/0.4 (Voluven)', 'description': '6% HES 130/0.4 during surgery\n\nHES 130/0.4 (Voluven)'}, {'id': 'FG001', 'title': 'Human Albumin 5%', 'description': 'human albumin 5% during surgery\n\nhuman albumin 5%'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '72'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Did not receive intervention due to euvolemia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'did not receive intervention due to circulatory arrest', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'did not receive intervention due to logistic reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '9 more patients were recruited due to withdrawal (patients did not receive any treatment).', 'preAssignmentDetails': '9 more patients were recruited to ensure enough power after excluding patients who were randomized but they withdrew from the study and did not receive any treatment (see periods section for details).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'HES 130/0.4 (Voluven)', 'description': '6% HES 130/0.4 during surgery\n\nHES 130/0.4 (Voluven)'}, {'id': 'BG001', 'title': 'Human Albumin 5%', 'description': 'human albumin 5% during surgery\n\nhuman albumin 5%'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71', 'spread': '10', 'groupId': 'BG000'}, {'value': '69', 'spread': '9', 'groupId': 'BG001'}, {'value': '70', 'spread': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}]}, {'title': 'Not reported', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes', 'classes': [{'title': 'Type 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Type 2', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertension', 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Stroke', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Myocardial infarction', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Surgery type', 'classes': [{'categories': [{'title': 'Aortic valve only', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}, {'title': 'Aortic valve + CABG', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Aortic valve + other', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Aortic valve + CABG + other', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of aortic cross-clamp', 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000', 'lowerLimit': '48', 'upperLimit': '91'}, {'value': '60', 'groupId': 'BG001', 'lowerLimit': '45', 'upperLimit': '89'}, {'value': '62', 'groupId': 'BG002', 'lowerLimit': '46', 'upperLimit': '90'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Total fluid', 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'BG000', 'lowerLimit': '2.3', 'upperLimit': '3.2'}, {'value': '2.8', 'groupId': 'BG001', 'lowerLimit': '2.1', 'upperLimit': '3.7'}, {'value': '2.8', 'groupId': 'BG002', 'lowerLimit': '2.1', 'upperLimit': '3.5'}]}]}], 'paramType': 'MEDIAN', 'description': 'total fluid is the amount of colloids and crystalloids during surgery', 'unitOfMeasure': 'L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Transfusion', 'classes': [{'title': 'Red blood cell', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Platelets', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Fresh frozen plasma', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Cryoprecipitate', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Transfusion', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '"Transfusion" Row is reporting the total number of participants who had at least one transfusion', 'unitOfMeasure': 'Participants'}, {'title': 'Volume of study solution', 'classes': [{'categories': [{'measurements': [{'value': '500', 'groupId': 'BG000', 'lowerLimit': '400', 'upperLimit': '750'}, {'value': '750', 'groupId': 'BG001', 'lowerLimit': '500', 'upperLimit': '1000'}, {'value': '620', 'groupId': 'BG002', 'lowerLimit': '460', 'upperLimit': '800'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ml', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Previous cardiac surgery', 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Use of antifibrinolytic drug', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-19', 'size': 1301673, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-05-20T08:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2020-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-09', 'studyFirstSubmitDate': '2014-07-15', 'resultsFirstSubmitDate': '2022-09-21', 'studyFirstSubmitQcDate': '2014-07-15', 'lastUpdatePostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-09', 'studyFirstPostDateStruct': {'date': '2014-07-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urine Neutrophil Gelatinase-associated Lipocalin (NGAL) [Time Frame: 24 Hours After Surgery] [Designated as Safety Issue: Yes]', 'timeFrame': '3 measurements in total from baseline to 24 hours after surgery: the first one is at baseline; the second one is at one hour of arrive to ICU and last one is at 24 hours after surgery', 'description': 'To assess the safety of HES 130/0.4 (Voluven) versus albumin 5% on renal function we will measure urinary concentrations of neutrophil gelatinase-associated lipocalin (NGAL), an important marker of renal function, measured at baseline (following anesthetic induction and prior to surgical incision), at one hour of arrival to intensive care unit (ICU), at 24 hours following completion of surgery.'}], 'secondaryOutcomes': [{'measure': 'Kidney Function', 'timeFrame': 'within first 7 postoperative days', 'description': 'Postoperative kidney dysfunction using RIFLE diagnostic criteria was also assessed. Patients were assessed for risk for kidney dysfunction (RIFLE-R), injury to the kidney (RIFLE-I), failure of kidney function (RIFLE-F) using criteria based on only peak serum creatinine concentrations within the first seven postoperative days. Due to too few events, this outcome was redefined to risk (or worse) vs. no risk for this analysis.\n\nRIFLE classification criteria is listed below:\n\nRisk (RIFLE-R) Increase in serum creatinine x 1.5 from baseline Injury (RIFLE-I) Increase in serum creatinine x 2 from baseline Failure (RIFLE-F) Increase in serum creatinine x 3 from baseline Loss (RIFLE-L) Complete loss of kidney function \\> 4 weeks End stage (RIFLE-E) End-stage kidney failure \\> 3 months'}, {'measure': 'Postop Urine IL-18', 'timeFrame': 'postoperative 1 hour', 'description': 'Postop Urine IL-18 (interleukin-18) measured at 1 h of arrival to ICU'}, {'measure': 'Postop Urine IL-18', 'timeFrame': '24 hours after surgery', 'description': 'Postoperative urine IL-18 (interleukin-18) measured at 24 hours after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Postoperative Kidney Injury']}, 'referencesModule': {'references': [{'pmid': '34406128', 'type': 'DERIVED', 'citation': 'Lee MJ, Tannenbaum C, Mao G, Jia Y, Leung S, Yilmaz HO, Ince I, Soltesz E, Duncan AE. Effect of 6% Hydroxyethyl Starch 130/0.4 on Inflammatory Response and Pulmonary Function in Patients Having Cardiac Surgery: A Randomized Clinical Trial. Anesth Analg. 2021 Oct 1;133(4):906-914. doi: 10.1213/ANE.0000000000005664.'}, {'pmid': '33744114', 'type': 'DERIVED', 'citation': 'Katabi LJ, Pu X, Yilmaz HO, Jia Y, Leung S, Duncan AE. Prognostic Utility of KDIGO Urine Output Criteria After Cardiac Surgery. J Cardiothorac Vasc Anesth. 2021 Oct;35(10):2991-3000. doi: 10.1053/j.jvca.2021.02.027. Epub 2021 Feb 13.'}, {'pmid': '32072617', 'type': 'DERIVED', 'citation': 'Duncan AE, Jia Y, Soltesz E, Leung S, Yilmaz HO, Mao G, Timur AA, Kottke-Marchant K, Rogers HJ, Ma C, Ince I, Karimi N, Yagar S, Trombetta C, Sessler DI. Effect of 6% hydroxyethyl starch 130/0.4 on kidney and haemostatic function in cardiac surgical patients: a randomised controlled trial. Anaesthesia. 2020 Sep;75(9):1180-1190. doi: 10.1111/anae.14994. Epub 2020 Feb 18.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the safety of a standard volume replacement called HES 130/0.4 (Voluven) during surgery on recovery. HES 130/0.4 (Voluven) may offer an alternative to pure fluid replacement solutions that are associated with problems after surgery including fluid overload and respiratory difficulties. The safety of HES 130/0.4 (Voluven) will be evaluated by examining its effects on kidney function, and coagulation parameters and platelet (part of the blood that help it clot) function.\n\nParticipants will be randomized (like flipping a coin) to receive one of two possible volume replacements during surgery, if fluid volume decreases enough to need replacement with one of the fluids. The two possible volume replacements are Voluven (a starch-containing fluid) or human albumin 5% (a protein-containing solution).\n\nTo examine kidney function, urine will be-sampled when the participant is put under general anesthesia, before surgical incision, within one hour of arrival to the ICU and 24 hours after completion of surgery. Two tubes (2 teaspoons) of blood (from an already established line) will be taken the morning of the surgery, within one hour of arrival to the ICU, 24 hours after surgery and every morning during the participants postoperative ICU stay.\n\nAdditionally, health and recovery information will be recorded from the participant's medical record. We will phone participants around 90 days and one year after surgery to ask a few questions about one's health and recovery. We will also record blood sample analysis results from follow up appointments within the first year after surgery. If this analysis is not conducted at the Cleveland Clinic, with permission, we will obtain the results from a treating physician."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 50 - 85 years old\n* Scheduled for elective aortic valve replacement with or without coronary artery bypass grafting with or without additional minor surgical procedure.\n* Written, informed consent for participation in this investigation.\n\nExclusion Criteria:\n\n* Patients with renal failure with oliguria or anuria not related to hypovolemia.\n* Patients receiving dialysis.\n* Patients with preoperative renal insufficiency (Creatinine \\> 1.6 mg/dL)\n* Anticipated deep hypothermic circulatory arrest\n* Known hypersensitivity or allergy to hydroxyethyl starch or the excipients of hydroxyethyl starch\n* Clinical conditions with volume overload (e.g., patients in pulmonary edema or congestive heart failure)\n* Patients with severe hypernatremia or severe hyperchloremia\n* Patients with intracranial bleeding\n* Pregnant or breast feeding women\n* Critically ill adult patients, including patients with sepsis, due to increased risk of mortality and renal replacement therapy, (e.g. patients who are hospitalized in the intensive care unit prior to surgery)\n* Severe liver disease\n* Pre-existing coagulation or bleeding disorders\n* Any contraindications to proposed interventions.'}, 'identificationModule': {'nctId': 'NCT02192502', 'acronym': 'SHARP', 'briefTitle': 'Use of 6% Hydroxyethylstarch (130/0.4) in Cardiac Surgical Patients', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'A Randomized Controlled Investigation of the Effects of 6% Hydroxyethylstarch 130/0.4 (Voluven) on Renal Function in Patients Having Aortic Valve Replacement With or Without Coronary Artery Bypass Grafting', 'orgStudyIdInfo': {'id': '012-973'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HES 130/0.4 (Voluven)', 'description': '6% HES 130/0.4 during surgery', 'interventionNames': ['Drug: HES 130/0.4 (Voluven)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'human albumin 5%', 'description': 'human albumin 5% during surgery', 'interventionNames': ['Drug: human albumin 5%']}], 'interventions': [{'name': 'human albumin 5%', 'type': 'DRUG', 'armGroupLabels': ['human albumin 5%']}, {'name': 'HES 130/0.4 (Voluven)', 'type': 'DRUG', 'armGroupLabels': ['HES 130/0.4 (Voluven)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Andra Duncan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fresenius Kabi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}