Adult patients discharged alive from ICU with a decreased eGFR, and/or an AKI during ICU stay and/or an elevated NT-proBNP at discharge.
Conditions
Brief summary
A composite outcome composed of: • all-cause mortality, at one year after ICU discharge • and/or unscheduled hospital hospitalization for heart failure, at one year after ICU discharge • and/or a decrease of eGFR by more than 50% from baseline (ICU discharge) and/or end stage kidney disease defined as an eGFR<15ml/min/1.73m² and/or initiation of renal replacement therapy and/or kidney transplantation at one year after ICU discharge
Detailed description
Unscheduled hospital hospitalization for cardiovascular events (acute heart failure, stroke, acute coronary syndrome) during the year following ICU discharge, Occurrence of severe chronic kidney disease one year after ICU discharge defined as eGFR <30 ml/min/1.73m2, Decrease of estimated glomerular filtration rate of more than 50% from baseline one year after ICU discharge, New episode of acute kidney injury (according to the KDIGO criteria) requiring hospitalization in the year following ICU discharge, Occurrence of end stage kidney disease defined (eGFR<15ml/min/1.73m2) and/or initiation of renal replacement therapy and/or kidney transplantation one year after ICU discharge, Variation of NT-proBNP or BNP, eGFR between 12 months (end of treatment) and 12 months + 6 weeks (end of study), Occurrence of cardiovascular events during of the treatment duration, Occurrence of renal events during of the treatment duration, Occurrence of global outcome events during of the treatment duration, Safety endpoints are evaluated during the year after ICU discharge: Urinary tract infection / Necrotizing fasciitis / Symptomatic Diabetic ketoacidosis (Arterial pH <7.3 and Ketone-positive urine and Anion gap <10 mEq/L and Drowsy, stupor or coma) / Major hypoglycaemia (glycemia < 3mmol/L) / Death of any cause
Interventions
DRUGPlacebo du FORXIGA 10 mg
DRUGForxiga 10 mg film-coated tablets
Sponsors
Assistance Publique Hopitaux De Paris
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A composite outcome composed of: • all-cause mortality, at one year after ICU discharge • and/or unscheduled hospital hospitalization for heart failure, at one year after ICU discharge • and/or a decrease of eGFR by more than 50% from baseline (ICU discharge) and/or end stage kidney disease defined as an eGFR<15ml/min/1.73m² and/or initiation of renal replacement therapy and/or kidney transplantation at one year after ICU discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| Unscheduled hospital hospitalization for cardiovascular events (acute heart failure, stroke, acute coronary syndrome) during the year following ICU discharge, Occurrence of severe chronic kidney disease one year after ICU discharge defined as eGFR <30 ml/min/1.73m2, Decrease of estimated glomerular filtration rate of more than 50% from baseline one year after ICU discharge, New episode of acute kidney injury (according to the KDIGO criteria) requiring hospitalization in the year following ICU discharge, Occurrence of end stage kidney disease defined (eGFR<15ml/min/1.73m2) and/or initiation of renal replacement therapy and/or kidney transplantation one year after ICU discharge, Variation of NT-proBNP or BNP, eGFR between 12 months (end of treatment) and 12 months + 6 weeks (end of study), Occurrence of cardiovascular events during of the treatment duration, Occurrence of renal events during of the treatment duration, Occurrence of global outcome events during of the treatment duration, | — |
Countries
France
Outcome results
None listed