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Recruiting
NCT05621551
Dapagliflozin Therapy In Cardiac Surgery
Conditions: Diabetes Mellitus, Type 2, Cardiac Surgery
Sex: All
Ages: 18 Years – N/A
Phase: PHASE4
Enrollment: 178
Sponsor: China National Center for Cardiovascular Diseases
Location: China
Summary
This randomized controlled trial is to assess the effects of perioperative dapagliflozin on type 2 diabetic patients undergoing cardiac surgery
Eligibility Criteria
Inclusion Criteria:Age ≥ 18 years at screeningScheduled for cardiac surgeryDiagnosis of Type 2 DiabetesProvision of signed informed consent prior to any study specific proceduresExclusion Criteria:Emergency surgery and non-primary surgeryModerate and severe dehydration; systolic pressure≤90mmHg; unstable haemodynamicsHistory of diabetic ketoacidosis; type 1 diabetes mellitusReceiving therapy with an SGLT2 inhibitor within 4 weeks prior to enrolmentKnown allergy or hypersensitivity to dapagliflozin or other SGLT-2 inhibitorsEstimated glomerular filtration rate (eGFR) <30 mL/min/1.73
m2 or requiring dialysis; unstable or rapidly progressing renal disease at the time of randomisationSerious hepatic diseaseWomen who are pregnant, nursing, or who plan to become pregnant while in the trialCurrently enrolled in another investigational drug study, or less than 30 days
Source: ClinicalTrials.gov (NCT05621551). StuddyBuddy aggregates publicly available trial information.