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

Sponsor
Amsterdam UMC
Study ID
NCT05590143
Phase
PHASE4
Status
Active Not Recruiting

Conditions

  • Acute Kidney Injury
  • Cardiac Surgery
  • Sodium-Glucose Transporter 2 Inhibitor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 9, 2023
Status verified
May 2025
Primary completion
May 14, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
784 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention
    Dapagliflozin 10 mg
  • Placebo Comparator: Placebo
    Matching Placebo

Primary Outcome Measure

AKI [ Time Frame: Recorded daily until day 7 postoperatively or until discharge from hospital (earlier). ]

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