Effects of Perioperative Dapagliflozin on Type 2 Diabetic Patients Undergoing Cardiac Surgery
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 178
- Locations
- 1
- Primary Endpoint
- Hs-Troponin-I
Study Overview
Brief Summary
This randomized controlled trial is to assess the effects of perioperative dapagliflozin on type 2 diabetic patients undergoing cardiac surgery
Detailed Description
Sodium-Glucose Cotransporter 2 Inhibitor(SGLT2i) including dapagliflozin are widely used in the clinical treatment of type 2 diabetes mellitus(T2DM). In recent studies, SGLT2i were found to not only reduce blood glucose but also protect the heart and kidney, which can significantly reduce cardiovascular events, delay the progression of renal failure, greatly improve the quality of life of patients. Patients with T2DM have poorer cardiac surgery outcomes compared with non-diabetics. Based on the promising pharmacological profile of dapagliflozin, we hypothesize that perioperative dapagliflozin therapy would improve postoperative outcomes among patients undergoing cardiac surgery with T2DM. This randomized controlled trial is to assess the effects of perioperative dapagliflozin on type 2 diabetic patients undergoing cardiac surgery
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years at screening
- •Scheduled for cardiac surgery (on-pump coronary artery bypass grafting, aortic valve replacement, or a combination of both)
- •Diagnosis of Type 2 Diabetes
- •Provision of signed informed consent prior to any study specific procedures
Exclusion Criteria
- •Emergency surgery and non-primary surgery
- •Moderate and severe dehydration; systolic pressure≤90mmHg; unstable haemodynamics
- •History of diabetic ketoacidosis; type 1 diabetes mellitus
- •Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to enrolment
- •Known allergy or hypersensitivity to dapagliflozin or other SGLT-2 inhibitors
- •Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 or requiring dialysis; unstable or rapidly progressing renal disease at the time of randomisation
- •Serious hepatic disease
- •Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- •Currently enrolled in another investigational drug study, or less than 30 days
Arms & Interventions
Dapagliflozin
Dapagliflozin 10 mg
Intervention: Dapagliflozin (Drug)
Outcomes
Primary Outcomes
Hs-Troponin-I
Time Frame: within 2 days after surgery
high sensitive cardiac troponin-I
Secondary Outcomes
- Renal function(within 5 days after surgery)
- ICU stay(an average of 3 days)
- NT-proBNP(within 5 days after surgery)
- Postoperative atrial fibrillation(within 5 days after surgery)
- Perioperative myocardial infarction(In-hospital time, an average of 2 weeks)
- cardiac systolic function(within 5 days after surgery)
- cardiac diastolic function(within 5 days after surgery)
- Inflammatory biomarkers(within 5 days after surgery)
- Abnormal blood potassium concentration(within 5 days after surgery)
- Hs-Troponin-I(within 5 days after surgery)
- postoperative blood glucose level(within 5 days after surgery)
- Length of in-hospital time(an average of 2 weeks)