Dapagliflozin for Cardio-renal Protection After ICU Discharge

Phase III study Prospective, multicenter, superiority, double-blind, randomized controlled study with two arms (1:1). Every patient will be screened in the 48h before ICU discharge for trial inclusion and non-inclusion criteria until 72h hours after ICU discharge. After providing written informed consent, patients will be randomly assigned to receive either dapagliflozin (at a dose of 10 mg once daily) or matching placebo, in accordance with the sequestered, fixed-randomization schedule, with the use of balanced blocks to ensure an approximate 1:1 ratio of the two regimens for one year. Four visits are planned, one at inclusion (V0), one at 6 months (V1), one at the end of the treatment (V2 at one year), one 6 weeks after the end of the treatment (V3, end of the study) and two phone calls at 3 (Phone call 1) and 9 months (phone call 2). At 6 months (V1) and at 12 months (V2) visits, a clinical exam and biological analysis will be performed at hospital (i.e., HbA1c, glucose level, ionogram, NT-proBNP or BNP, serum creatinine, hematocrit and pregnancy urinary test) by anesthesiologists, cardiologists or nephrologists, to assess primary and secondary endpoints, including eGFR. At 12 months + 6 weeks (V3) visit, a clinical exam and biological analysis will be performed at hospital (i.e., glucose level, NT-proBNP or BNP, serum creatinine) by anesthesiologists, cardiologists or nephrologists, to assess primary and secondary endpoints, including eGFR. The phone calls, at 3 and 9 months, will be made by the designated persons and respecting the confidentiality and security of the data collected. At inclusion (V0) and at 6 months (V1) the treatment will be deliver for the next 6 months. At 6 months (V1), the patient will pick up his treatment at the hospital. Primary endpoints will be assessed at 6 and 12 months visit and phone calls (3 and 9 months). Secondary endpoints will be assessed at each visit and phone calls (3, 6, 9, 12 and 12 + 6 weeks). eGFR (glomerular filtration rate) will be assessed only at 6, 12 months and 12 + 6 weeks. The eGFR (glomerular filtration rate) will not be assessed at phone calls. At each visit and phone calls, adverse events and severe adverse events will also be assessed.