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proMoting Effective Renoprotection in Cardiac sURgery Patients by Inhibition of SGLT-2
Sponsor: Amsterdam UMC
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.
Official title: Preoperative Sodium Glucose Cotransporter 2 Inhibitors for Prevention of Postoperative Acute Kidney Injury in Cardiac Surgery Patients - a Randomized, Placebo-controlled, Multi-centre, Phase IV Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
784
Start Date
2023-06-09
Completion Date
2025-09
Last Updated
2025-05-18
Healthy Volunteers
No
Interventions
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).
Locations (6)
OLVG
Amsterdam, Netherlands
Amsterdam UMC
Amsterdam, Netherlands
Amphia Hospital
Breda, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
Leiden University Medical Center
Leiden, Netherlands
St Antonius Hospital
Nieuwegein, Netherlands