Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-01 @ 7:04 PM
Study NCT ID:
NCT06825156
Status:
COMPLETED
Last Update Posted:
2025-02-13
First Post:
2025-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic and Renal Outcomes in Cardiac Surgery Patients Receiving SGLT2 Inhibitors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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': 'C570240', 'term': 'empagliflozin'}, {'id': 'D000077203', 'term': 'Sodium-Glucose Transporter 2 Inhibitors'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D007004', 'term': 'Hypoglycemic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-center, open-label parallel-group randomized, controlled(usual care), phase IV clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-08', 'studyFirstSubmitDate': '2025-02-08', 'studyFirstSubmitQcDate': '2025-02-08', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Ketoacidosis', 'timeFrame': 'During study period untill post-operative day 4', 'description': 'Incidence of keto-acidosis defined as combination of blood ketone concentration \\>3mmol/l in combination with high-anion gap acidosis (\\[Na+\\]-\\[Cl-\\]-\\[HCO3-\\]\\>12).'}, {'measure': 'Hypoglycemia', 'timeFrame': 'During study period untill post-operative day 4', 'description': 'Incidence of Hypoglycemia during study period'}], 'primaryOutcomes': [{'measure': 'NGAL', 'timeFrame': 'Day 2 post surgery', 'description': 'Neutrophil gelatinase-associated lipocalin (NGAL) concentration in plasma on postoperative day 2'}], 'secondaryOutcomes': [{'measure': 'Neutrophil gelatinase-associated lipocalin (NGAL) concentration in plasma.', 'timeFrame': 'Before surgery, day of surgery, day 1+2 after surgery', 'description': 'NGAL measured in plasma'}, {'measure': 'Kidney Injury Molecule-1 (KIM-1) in plasma.', 'timeFrame': 'Before surgery, day of surgery, day 1+2 after surgery', 'description': 'KIM-1 concentration measured in plasma'}, {'measure': 'Perioperative peak and average blood glucose levels, as measured during usual care.', 'timeFrame': 'During study per untill 4 days post-operatively', 'description': 'Glucose levels recorded during usual routine care'}, {'measure': 'Blood ketone levels.', 'timeFrame': 'During surgery at 4 measurement moments or during usual care.', 'description': 'Blood ketones measured intra-operatively'}, {'measure': 'Renal functioning (KDIGO criteria)', 'timeFrame': 'During study period untill post-operative day 4', 'description': 'development of serum creatinine levels and urine output measured untill post-operative day 4'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CSA-AKI', 'SGLT-2i', 'Cardiac surgery'], 'conditions': ['Acute Kidney Injury']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-003172-13/NL', 'label': 'Link of the former published study protocol, National register of the Netherlands has ceased to exist.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the potential of preoperative initiation (3 days) and perioperative continuation (until day 2 after surgery) of empagliflozin(sodium glucose co transporter 2 inhibitor(SGLT-2i)) 10 mg daily to reduce the acute kidney injury marker neutrophil gelatinase-associated lipocalin (NGAL) measured in serum and urine on day 2 postoperatively in patients undergoing cardiopulmonary bypass surgery by comparing a study medication group to a control group in an open-label set-up.', 'detailedDescription': 'Adult patients scheduled for elective cardiopulmonary bypass assisted cardiothoracic surgery will be informed about the study and after receiving informed consent will be divided between two groups in an openlabel fashion:\n\nIntevention group: Takes study medication(10mg Empagliflozin once a day in the morning) 3 days prior to surgery, day of surgery and 2 days post-surgery.\n\nControl group: follows the usual standard of care. At time moment before surgery and before medication is taken blood and urine sample is taken. This is repeated on day of surgery, and the consecutive 2 days after surgery.\n\nForm these samples biomakers for kidney injury will be measured and compared between groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 90 years old (inclusive)\n* Undergoing elective cardiac surgery with cardio-pulmonary bypass.\n* Providing informed consent\n\nExclusion Criteria:\n\nCurrent treatment with SGLT2 inhibitors.\n\n* Diabetes Mellitus Type 1\n* BMI\\<25 for people with type 2 diabetes\n* Reduced renal function at baseline with eGFR \\< 30 ml/min.\n* Systolic blood pressure \\< 100 mmHg at time of inclusion.\n* Emergency surgery, defined as in need of surgery for medical reasons \\< 7 days, i.e. "S1-4" according to the Amsterdam UMC classification.\n* Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods.\n* Known or suspected allergy to trial products or other drugs in the same class.'}, 'identificationModule': {'nctId': 'NCT06825156', 'acronym': 'MERCURI', 'briefTitle': 'Metabolic and Renal Outcomes in Cardiac Surgery Patients Receiving SGLT2 Inhibitors', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'The Perioperative Renal and Metabolic Outcomes After Sodium Glucose Cotransporter 2 Inhibitor in Cardiac Surgery - an Open-label Phase IV Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'NL78156.018.21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Controlled (usual care)', 'description': 'Standard of care, Some additional blood drawn and urine collected to compare between both groups'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention(Medication group)', 'description': 'Patients receive 10mg Empagliflozin(SLGT-2i) daily from 3 days prior to surgery untill 2 days post-surgery which includes day of surgery.', 'interventionNames': ['Drug: Empagliflozin 10 MG']}], 'interventions': [{'name': 'Empagliflozin 10 MG', 'type': 'DRUG', 'otherNames': ['Gliflozin', 'SGLT-2i'], 'description': 'Patients receive 10mg Empagliflozin(SLGT-2i) daily from 3 days prior to surgery untill 2 days post-surgery which includes day of surgery.', 'armGroupLabels': ['Intervention(Medication group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105 AZ', 'city': 'Amsterdam-Zuidoost', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Amsterdam University Medical Centre', 'geoPoint': {'lat': 52.3075, 'lon': 4.97222}}], 'overallOfficials': [{'name': 'Jeroen Hermanides, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amsterdam University Medical Centre'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'at least 5 years after publication', 'ipdSharing': 'YES', 'description': 'Protocol', 'accessCriteria': 'Relevant reason to validate the request for access of this data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Commission', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Drs.', 'investigatorFullName': 'Lars Ivar Pieter Snel', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}