IRBESARTAN for Acute kidney injury

Inclusion criteria

• {"criterion_text":"- Male or female patients ≥ 18 years of age\n- Met criteria for acute kidney injury during the ICU stay (according to the KDIGO criteria)\n- After their renal function has stabilized for at least 48 hours (Serum creatinine decreasing or not increasing more than 26 micromol/L or 25%) among patients ready to be discharged from the ICU or TCU. and within 30 days after their discharge.\n- Patient affiliated to a Social Security System\n- Women of childbearing potential and men must agree, to use adequate and highly effective contraception, until the end of the research."}

Exclusion criteria

• {"criterion_text":"- Patient treated with ACEi or ARB before ICU admission\n- Known hypersensitivity to the active substance or to one of its excipients and in particular to lactose\n- Patients with known primary hyperaldosteronism\n- Patients with known severe and symptomatic aortic stenosis, mitral stenosis or obstructive hypertrophic cardiomyopathy.\n- Patients treated with lithium\n- Inability to consent due to psychiatric disorders defined as psychiatric disorders or patient with a mental state requiring immediate care with either by constant medical surveillance justifying hospitalization, or regular medical follow-up justifying specific treatment.\n- Patients deprived of liberty by a judicial or administrative decision\n- Patient to a legal protection measure (guardianship, curatorship and safeguard of justice)\n- Patient for whom treatment with ACEi or ARA is strongly recommended according to the international guidelines (ie patients with congestive heart failure and persistent dyspnea with LVEF<40%, patients with diabetes mellitus AND [either albuminuria > 30mg /g creatininury or hypertension associated with microalbuminuria or hypertension associated with eGFR < 60 ml/min) known before ICU admission\n- Hyperkalemia > 5 mmol/L at ICU discharge\n- Systolic blood pressure <100 mmHg at ICU discharge\n- Patient with severe renal failure, as defined by estimated glomerular filtration rate creatinine clearance < 15 ml/min/1.73m2), requiring renal replacement therapy at ICU discharge\n- Oral route impossible\n- Pregnancy\n- Breast feeding\n- Patients chronically treated with Aliskiren"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint of the trial is the time to MACE (major adverse cardiovascular events), i.e. a composite outcome composed of all-cause mortality and all unscheduled hospital readmission for cardiovascular events (acute heart failure, stroke, acute coronary syndrome) during the year following ICU or TCU discharge","definition_or_measurement_approach":"Time-to-event (time to first occurrence) of MACE defined as a composite of all-cause mortality and any unscheduled hospital readmission for cardiovascular events (acute heart failure, stroke, acute coronary syndrome) during the 1 year after ICU/TCU discharge."}

Secondary endpoints

• {"endpoint_text":"- Albuminuria >0.3 g/day one year after ICU or TCU discharge","definition_or_measurement_approach":"Albuminuria measured at one year; threshold >0.3 g/day."}
• {"endpoint_text":"- Occurrence of chronic kidney disease one year after ICU or TCU discharge defined as eGFR <60 ml/min/1.73m2","definition_or_measurement_approach":"Chronic kidney disease defined as eGFR <60 ml/min/1.73 m2 assessed one year after discharge."}
• {"endpoint_text":"- Decrease of estimated glomerular filtration from baseline to one year after enrollment","definition_or_measurement_approach":"Change in eGFR from baseline to one year."}
• {"endpoint_text":"- Change in Chronic kidney disease staging one year after enrollment","definition_or_measurement_approach":"CKD stage change assessed at one year compared with baseline staging."}
• {"endpoint_text":"- New episode of acute kidney injury (according to the KDIGO criteria) requiring hospitalization","definition_or_measurement_approach":"Occurrence of AKI per KDIGO criteria that requires hospital admission."}
• {"endpoint_text":"- Hyperkalemia >6 mmol/L","definition_or_measurement_approach":"Biochemical measurement of serum potassium >6 mmol/L."}
• {"endpoint_text":"- Death","definition_or_measurement_approach":"All-cause mortality."}
• {"endpoint_text":"- Biological collection built up at inclusion and at the end of the study","definition_or_measurement_approach":"Collection of biological samples at inclusion and at study end for biomarker/factor analyses."}

France

Earliest CTIS Part Ii Submission Date

21-10-2024

Latest Decision Or Authorization Date

23-10-2024

Processing Time Days

2

Number Of Sites

32

Number Of Participants

508

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France