proMoting Effective Renoprotection in Cardiac sURgery Patients by Inhibition of SGLT-2

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Multi-centre, triple-blinded (patients, physicians, investigators), parallel-group, balanced (1:1), stratified (male-female 50-50), randomized, controlled (placebo), phase IV clinical trial to investigate the potential of preoperative initiation (from day 1 before surgery) and perioperative continuation (until day 2 after surgery) of the SGLT2 inhibitor dapagliflozin 10 mg once daily to prevent AKI according to the KDIGO criteria (an increase in serum creatinine by 0.3 mg/dl (26.5 mmol/l) within 48 hours; or an increase in serum creatinine to 1.5 times baseline, within 7 days; or a urine output <0.5 ml/kg/h for >6 hours) in adult (>18 years old) patients undergoing cardiopulmonary bypass surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborator: ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Dapagliflozin; Sodium-Glucose Transporter 2 Inhibitors

Criteria

Inclusion Criteria:

1. > 18 years-old

2. Undergoing elective cardiac surgery.

3. Providing informed consent

Exclusion Criteria:

1. Current treatment with SGLT2 inhibitors

2. Reduced kidney function at baseline with eGFR < 20 ml/min at time of inclusion

3. Diabetes Mellitus Type 1

4. History of diabetic keto acidosis

5. Diabetes Mellitus Type 2 with BMI<25 for people with type 2 diabetes who are using multiple daily insulin injections (both short and long-acting insulin)

6. Systolic blood pressure < 100 mmHg at time of inclusion

7. Emergency surgery, defined as in need of surgery for medical reasons < 7 days, i.e. "S1-4" according to the Amsterdam UMC classification

8. Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods

9. Known or suspected allergy to trial products or other drugs in the same class