Impact of a Treatment With Angiotensin Receptor Blocker on Outcome After Acute Kidney Injury in Patients Discharged From the ICU. (START-or-NOT)
Acute Kidney Injury
About this trial
This is an interventional treatment trial for Acute Kidney Injury focused on measuring Angiotensin-Converting-Enzyme Inhibitor, angiotensin-receptor blockers
Eligibility Criteria
Inclusion Criteria:
- Patient between 18 and 75 years old
- Met criteria for acute kidney injury during the ICU stay (according to the KDIGO criteria)
- After their renal function has stabilized for at least 48 hours (changes in serum creatinine < 26 micromol/L or < 25%) among patients ready to be discharged from the ICU or within 30 days after ICU discharge.- Signed informed consent
- Patients affiliated to a Social Security System
- Women of childbearing potential and men must agree, to use adequate and highly effective contraception, until the end of the research.
Exclusion Criteria:
- Patient treated with ACEi or ARB before ICU admission
- Patient for whom treatment with ACEi or ARB is strongly recommended according to the international guidelines at discharge (i.e. patients with congestive heart failure and persistent dyspnea with LVEF<40%,, patients with diabetes mellitus and either albuminuria > 300 µg/g creatininuria or hypertension associated with microalbuminuria or hypertension associated with eGFR < 60 ml/min) known before ICU admission.
- Hyperkalemia>5 mmol/L
- Systolic blood pressure <100 mmHg
- 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
- Oral route impossible.
- Pregnancy
- Breast feeding
- Patients chronically treated with Aliskiren
- Known hypersensitivity to the active substance or to one of its excipients and in particular to lactose
- Patients with known primary hyperaldosteronism
- Patients with known severe and symptomatic aortic stenosis, mitral stenosis or obstructive hypertrophic cardiomyopathy.
- Patients treated with lithium
- Patient undergoing psychiatric care
- 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
- Patient deprived of liberty by a judicial or administrative decision
- Patient to a legal protection measure (guardianship, curatorship and safeguard of justice)
Sites / Locations
- Hospital LariboisièreRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
IRBESARTAN
Placebo
IRBESARTAN will be introduced at 150 mg orally one daily, with a progressive increase to 300 mg a day, at 7 days or 2 months follow-up visit, based on clinical and biological tolerance. Treatment will be continued for 12 months, unless a side effect would occur.
Placebo will be introduced at 150 mg orally one daily, with a progressive increase to 300 mg a day, at 7 days or 2 months follow-up visit, based on clinical and biological tolerance. Treatment will be continued for 12 months, unless a side effect would occur.