Dapagliflozin Therapy In Cardiac Surgery
- Registration Number
- NCT05621551
- Lead Sponsor
- China National Center for Cardiovascular Diseases
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 178
- Age ≥ 18 years at screening
- Scheduled for cardiac surgery
- Diagnosis of Type 2 Diabetes
- Provision of signed informed consent prior to any study specific procedures
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dapagliflozin Dapagliflozin Dapagliflozin 10 mg
- Primary Outcome Measures
Name Time Method Hs-Troponin-I within 2 days after surgery high sensitive cardiac troponin-I
- Secondary Outcome Measures
Name Time Method Renal function within 5 days after surgery Change of creatinine values, need for renal replacement therapy
postoperative blood glucose level within 5 days after surgery hs-C-reactive protein within 5 days after surgery NT-proBNP within 5 days after surgery N-terminal prohormone of brain natriuretic peptide
Postoperative atrial fibrillation within 5 days after surgery In this study, postoperative AF was defined as occurrence of the arrhythmia within the first 5 days after cardiac surgery. AF was considered to be present when an irregular rhythm was detected in the absence of P waves and/or presence an f wave
cardiac function within 5 days after surgery Echocardiography is used to assess cardiac function
Abnormal blood potassium concentration within 5 days after surgery blood potassium concentration\<3.5mmol/L or \>5.5mmol/L
Hs-Troponin-I within 5 days after surgery
Trial Locations
- Locations (1)
National Clinical Research Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
🇨🇳Beijing, Beijing, China