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

Condition(s) studied

Investigational drug(s) / intervention(s)

Dapagliflozin 10 MG Oral Tablet [Farxiga]: One oral tablet, once daily starting one day prior to surgery and continued until two days postoperatively (four doses).

Placebo: One oral tablet, once daily starting one day prior to surgery and continued until two days postoperatively (four doses).

Study summary

Multi-centre, triple-blinded (patients, physicians, investigators), parallel-group, balanced (1:1), stratified (sex, type 2 diabetes mellitus), 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.

Eligibility

Primary outcome measure(s)

• AKI — Recorded daily until day 7 postoperatively or until discharge from hospital (earlier).
  Incidence of Acute Kidney Injury (AKI) occurring in 7 days after surgery, according to KDIGO criteria, defined as 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.

Trial sites (6)

More Amsterdam UMC trials in the Netherlands

Other trials for the same condition