proMoting Effective Renoprotection in Cardiac sURgery Patients by Inhibition of SGLT-2 (NCT05590143) | Clinical Trial Compass
Active — Not RecruitingPhase 4
proMoting Effective Renoprotection in Cardiac sURgery Patients by Inhibition of SGLT-2
Netherlands784 participantsStarted 2023-06-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. \> 18 years-old
✓. Undergoing elective cardiac surgery.
✓. Providing informed consent
Exclusion criteria
✕. Current treatment with SGLT2 inhibitors
✕. Reduced kidney function at baseline with eGFR \< 20 ml/min at time of inclusion
✕. Diabetes Mellitus Type 1
✕. History of diabetic keto acidosis
✕. 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)
✕. Systolic blood pressure \< 100 mmHg at time of inclusion
✕. Emergency surgery, defined as in need of surgery for medical reasons \< 7 days, i.e. "S1-4" according to the Amsterdam UMC classification
What they're measuring
1
AKI
Timeframe: Recorded daily until day 7 postoperatively or until discharge from hospital (earlier).