proMoting Effective Renoprotection in Cardiac sURgery Patients by Inhibition of SGLT-2
Status:
Not yet recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development