Ignite Creation Date:
2025-12-24 @ 1:55 PM
Ignite Modification Date:
2026-04-23 @ 6:00 AM
Study NCT ID:
NCT02405195
Status:
COMPLETED
Last Update Posted:
2019-05-07
First Post:
2015-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Renal Perfusion, Filtration and Oxygenation During Cardiopulmonary Bypass (CPB)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002315', 'term': 'Cardiopulmonary Bypass'}, {'id': 'D005112', 'term': 'Extracorporeal Circulation'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lukas.lannemyr@vgregion.se', 'phone': '46313428860', 'title': 'Lukas Lannemyr', 'organization': 'Västra Götalandsregionen'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Three days', 'description': 'Postoperative acute kidney injury, defined as an increase in serum-creatinine ≥50 % from baseline.', 'eventGroups': [{'id': 'EG000', 'title': 'CardioPulmonaryBypass', 'description': 'Open cardiac surgery with normothermic Cardiopulmonary Bypass at 2.5 L/min/m2.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 4, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Acute kidney injury', 'notes': 'Increase in serum-creatinine ≥50% from baseline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Renal Blood Flow (RBF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CardioPulmonaryBypass', 'description': 'Open cardiac surgery with normothermic Cardiopulmonary Bypass at 2.5 L/min/m2.'}], 'classes': [{'title': 'Pre CPB', 'categories': [{'measurements': [{'value': '554', 'spread': '126', 'groupId': 'OG000'}]}]}, {'title': 'CPB 30 minutes', 'categories': [{'measurements': [{'value': '524', 'spread': '116', 'groupId': 'OG000'}]}]}, {'title': 'CPB 60 minutes', 'categories': [{'measurements': [{'value': '564', 'spread': '162', 'groupId': 'OG000'}]}]}, {'title': 'Post CPB (30 - 60 minutes)', 'categories': [{'measurements': [{'value': '558', 'spread': '130', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.638', 'groupIds': ['OG000'], 'pValueComment': 'Bonferroni-Holm adjustment for multiple comparisons was used', 'groupDescription': 'Repeated measures ANOVA throughout measurement period (before, during and after CPB).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '6 hours', 'description': 'Renal blood flow measured with PAH clearance', 'unitOfMeasure': 'ml per minute per 1.73 m2 body surface', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Glomerular Filtration Rate (GFR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CardioPulmonaryBypass', 'description': 'Open cardiac surgery with normothermic Cardiopulmonary Bypass at 2.5 L/min/m2.'}], 'classes': [{'title': 'Before CPB', 'categories': [{'measurements': [{'value': '67', 'spread': '23', 'groupId': 'OG000'}]}]}, {'title': 'CPB 30 minutes', 'categories': [{'measurements': [{'value': '68', 'spread': '23', 'groupId': 'OG000'}]}]}, {'title': 'CPB 60 minutes', 'categories': [{'measurements': [{'value': '70', 'spread': '19', 'groupId': 'OG000'}]}]}, {'title': 'Post CPB (30 - 60 minutes)', 'categories': [{'measurements': [{'value': '67', 'spread': '18', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.972', 'groupIds': ['OG000'], 'pValueComment': 'Bonferroni-Holm adjustment for multiple comparisons was used', 'groupDescription': 'Repeated measures ANOVA', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '6 hours', 'description': 'GFR measured by renal extraction of 51Cr-EDTA', 'unitOfMeasure': 'ml per minute per 1.73 m2 body surface', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Renal Oxygenation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CardioPulmonaryBypass', 'description': 'Open cardiac surgery with normothermic Cardiopulmonary Bypass at 2.5 L/min/m2.'}], 'classes': [{'title': 'Pre CPB', 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'CPB 30 minutes', 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.05', 'groupId': 'OG000'}]}]}, {'title': 'CPB 60 minutes', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.06', 'groupId': 'OG000'}]}]}, {'title': 'Post CPB (30 - 60 minutes)', 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.05', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'Bonferroni-Holm adjustment for multiple comparisons was used', 'groupDescription': 'Repeated measures ANOVA', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '6 hours', 'description': 'Renal oxygen extraction, defined as renal oxygen consumption divided by renal oxygen delivery', 'unitOfMeasure': 'fraction', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Excretion of NAG', 'timeFrame': '24 hours', 'description': 'Urinary biomarker of tubular renal injury', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Development of Acute Kidney Injury (AKI)', 'timeFrame': '72 hours', 'description': 'AKI according to AKIN criteria', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CardioPulmonaryBypass', 'description': 'Open cardiac surgery with normothermic Cardiopulmonary Bypass at 2.5 L/min/m2.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CardioPulmonary Bypass', 'description': 'Open cardiac surgery with normothermic Cardiopulmonary Bypass at 2.5 L/min/m2.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Serum creatinine', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '87', 'spread': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'micromol per litre', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Left ventricular ejection fraction', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '58', 'spread': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-04', 'studyFirstSubmitDate': '2015-03-27', 'resultsFirstSubmitDate': '2018-04-27', 'studyFirstSubmitQcDate': '2015-03-27', 'lastUpdatePostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-04', 'studyFirstPostDateStruct': {'date': '2015-04-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Renal Blood Flow (RBF)', 'timeFrame': '6 hours', 'description': 'Renal blood flow measured with PAH clearance'}, {'measure': 'Glomerular Filtration Rate (GFR)', 'timeFrame': '6 hours', 'description': 'GFR measured by renal extraction of 51Cr-EDTA'}, {'measure': 'Renal Oxygenation', 'timeFrame': '6 hours', 'description': 'Renal oxygen extraction, defined as renal oxygen consumption divided by renal oxygen delivery'}], 'secondaryOutcomes': [{'measure': 'Excretion of NAG', 'timeFrame': '24 hours', 'description': 'Urinary biomarker of tubular renal injury'}, {'measure': 'Development of Acute Kidney Injury (AKI)', 'timeFrame': '72 hours', 'description': 'AKI according to AKIN criteria'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Complication of Extracorporeal Circulation', 'Renal Impairment']}, 'referencesModule': {'references': [{'pmid': '31919012', 'type': 'DERIVED', 'citation': 'Lannemyr L, Bragadottir G, Redfors B, Ricksten SE. Effects of milrinone on renal perfusion, filtration and oxygenation in patients with acute heart failure and low cardiac output early after cardiac surgery. J Crit Care. 2020 Jun;57:225-230. doi: 10.1016/j.jcrc.2019.12.022. Epub 2020 Jan 6.'}]}, 'descriptionModule': {'briefSummary': 'Acute kidney injury is a common complication after cardiac surgery with cardiopulmonary bypass (CPB). This study aims to investigate the effects of CPB on renal perfusion, filtration and oxygenation.', 'detailedDescription': "After approval of the regional ethics committee, patients (n=16) undergoing combined cardiac surgery procedures during normothermic CPB will be included after informed consent. Systemic and renal variables will be measured by pulmonary artery and renal vein catheters. Glomerular filtration rate (GFR) will be measured by renal extraction of 51Cr-EDTA and renal blood flow (RBF) by the infusion clearance technique for para-aminohippuric acid (PAH) corrected for by renal extraction of PAH. Repeated measures ANOVA followed by Fisher's PLSD post-hoc test were used for statistical analyses"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Elective complex cardiac surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preserved left ventricular function (LVEF \\> 50%)\n* Normal preoperative S-creatinine\n\nExclusion Criteria:\n\n* Contraindications to radiocontrast\n* Cardiac transplantation och dissection'}, 'identificationModule': {'nctId': 'NCT02405195', 'acronym': 'ECCSTUD', 'briefTitle': 'Renal Perfusion, Filtration and Oxygenation During Cardiopulmonary Bypass (CPB)', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'Renal Perfusion, Filtration and Oxygenation During Cardiopulmonary Bypass (CPB)', 'orgStudyIdInfo': {'id': 'SahlgrenskaUHThoraxLL0'}}, 'armsInterventionsModule': {'interventions': [{'name': 'cardiopulmonary bypass', 'type': 'PROCEDURE', 'otherNames': ['extracorporeal circulation'], 'description': 'During cardiac surgery, the subjects are routinely undergoing cardiopulmonary bypass'}]}, 'contactsLocationsModule': {'locations': [{'zip': '41345', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Department of thoracic anesthesia, Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Sven-Erik Ricksten, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sahlgrenska Academy, dept of clinical science'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Lukas Lannemyr', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}