Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-25 @ 7:39 PM
Study NCT ID:
NCT03405532
Status:
SUSPENDED
Last Update Posted:
2024-04-23
First Post:
2018-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Kidney Function in Diabetics During CPB (Cardio Pulmonary Bypass)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Not enough eligible patients leading to slow recruitment', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2018-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-21', 'studyFirstSubmitDate': '2018-01-05', 'studyFirstSubmitQcDate': '2018-01-19', 'lastUpdatePostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Renal O2 extraction', 'timeFrame': '2 years', 'description': 'Renal O2 extraction measured by sampling blood from a catheter inserted into the kidney vein.'}], 'secondaryOutcomes': [{'measure': 'GFR', 'timeFrame': '2 years', 'description': 'GFR (Glomerular filtration rate), measured with CrEDTA- and PAH- clearance.'}, {'measure': 'Renal blood flow', 'timeFrame': '2 years', 'description': 'Change in renal blood flow measured by sampling blood from a catheter inserted into the kidney vein'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Kidney, CPB']}, 'descriptionModule': {'briefSummary': 'Filtration of urine in the kidney requires sufficient oxygen supply. The filtration of urine is greater in patents with diabetes. Our theory is that the diabetic kidney has a higher oxygen demand than the non diabetic kidney thereby making the diabetic kidney more sensitive to decreased oxygen delivery following reduced blood flow. With a catheter inserted into the kidney vein we will monitor the blood flow and oxygen saturation before and during CPB, in patient with diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with diabetes mellitus undergoing surgery requiring CBP.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with diabetes mellitus\n* Serum creatinine \\< 150 micromol/L preoperative\n* Heart surgery requiring CPB\n* LV (left ventricle) EF \\>40 %\n* Normal hemoglobin\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03405532', 'acronym': 'DM-ECC', 'briefTitle': 'Kidney Function in Diabetics During CPB (Cardio Pulmonary Bypass)', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'The Effect of the CPB on Kidney Blood Flow, Function and Oxygen Uptake During Open Heart Surgery in Patients With Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'SahlgrenskaUHMT02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'DM-ECC', 'type': 'DIAGNOSTIC_TEST', 'description': 'Diabetes mellitus CPB'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Sven-Erik Ricksten, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sahlgrenska Universitetssjukhuset'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Maria Tholén', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}