Overview

Dapagliflozin Therapy In Cardiac Surgery

Status:
Recruiting

Trial end date:
2023-07-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

China National Center for Cardiovascular Diseases

Treatments:

Dapagliflozin

Criteria

Inclusion Criteria:

1. Age ≥ 18 years at screening

2. Scheduled for cardiac surgery

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