Impact of a treatment with angiotensin receptor blocker on outcome after acute kidney injury in patients discharged from the ICU START-or-NOT trial”.A prospective, randomized, double blinded, multicenter study

Phase 1

Conditions: MedDRA version: 26.0Level: PTClassification code 10069339Term: Acute kidney injurySystem Organ Class: 10038359 - Renal and urinary disorders
Therapeutic area: Body processes [G] - Physiological processes [G07]

Registration Number: EUCTR2020-000414-16-FR

Lead Sponsor: APHP

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 500

Inclusion Criteria

-Patient between 18 and 75 years old
-Met criteria for acute kidney injury during the ICU stay (according to the KDIGO criteria)
- Within 30 days after ICU discharge and after their renal function has stabilized for at least 48 hours (changes in serum creatinine < 26 micromol/L or < 25%).
- Signed informed consent
- Patient 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 250

Exclusion Criteria

Patient treated with ACEi or ARB before ICU admission
Patient for whom treatment with ACEi or ARB is stronglyrecommended according to the international guidelines at discharge (ie 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)]
Hyperkalemia > 5 mmol/L at ICU discharge
Systolic blood pressure <100 mmHg at ICU discharge
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 a contraindication to treatment with Irbesartan
Patients treated with diuretic, alpha-blocker, or NSAIDs