Dapagliflozin Therapy In Cardiac Surgery

National Center for Cardiovascular Diseases

Status and phase: Completed; Phase 4

Conditions: Cardiac Surgery; Diabetes Mellitus, Type 2

Treatments: Drug: Dapagliflozin

Study type: Interventional

Funder types: Other

Identifiers

NCT05621551

2021-1437

Details and patient eligibility

About

This randomized controlled trial is to assess the effects of perioperative dapagliflozin on type 2 diabetic patients undergoing cardiac surgery

Full 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

Enrollment: 178 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years at screening
2. Scheduled for cardiac surgery (on-pump coronary artery bypass grafting, aortic valve replacement, or a combination of both)
3. Diagnosis of Type 2 Diabetes
4. Provision of signed informed consent prior to any study specific procedures

Exclusion criteria

1. Emergency surgery and non-primary surgery
2. Moderate and severe dehydration; systolic pressure≤90mmHg; unstable haemodynamics
3. History of diabetic ketoacidosis; type 1 diabetes mellitus
4. Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to enrolment
5. Known allergy or hypersensitivity to dapagliflozin or other SGLT-2 inhibitors
6. 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
7. Serious hepatic disease
8. Women who are pregnant, nursing, or who plan to become pregnant while in the trial
9. Currently enrolled in another investigational drug study, or less than 30 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

178 participants in 2 patient groups

Dapagliflozin

Experimental group

Description:

Dapagliflozin 10 mg

Treatment:

Drug: Dapagliflozin

Standard of care

No Intervention group

Description:

Standard care treatment of diabetes patients during perioperative cardiac surgery in our center