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ACTIVE NOT RECRUITING

NCT05272878

PHASE3

Impact of a Treatment With Angiotensin Receptor Blocker on Outcome After Acute Kidney Injury in Patients Discharged From the ICU.

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

The patients discharged from intensive care units (ICU) have a high incidence of cardiovascular events and mortality rate during the year following ICU discharge. Among patients admitted to the ICU, patients with acute kidney injury (AKI) display high risk of such events. The investigators furthermore demonstrated that AKI could induce remote cardio-vascular injury and fibrosis, which may be involved in the poor prognosis of AKI. Strategies that may prevent the cardiovascular consequences of AKI in most severe patients (i.e. post-AKI ICU survivors) may therefore improve long term outcomes. AKI has been associated with activation of the renin-angiotensin-aldosterone system (RAAS). Activation of the RAAS has been further associated with long-term health consequences especially with cardiovascular damages. Potential protective effects of RAASi following acute injury have been reported in observational studies. With this randomized controlled trial, the investigators aim at investigating the impact of treatment with RAAS inhibitors after AKI on cardiovascular and kidney outcomes.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

508

Start Date

2022-11-22

Completion Date

2026-06-27

Last Updated

2025-09-08

Healthy Volunteers

Conditions

Acute Kidney Injury

Interventions

DRUG

IRBESARTAN, tablet, 150 mg

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.Treatment will be continued for 12 months, unless a side effect would occur.

DRUG

Placebo, tablet, 150 mg

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.Treatment will be continued for 12 months, unless a side effect would occur.

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 (Serum creatinine decreasing or not increasing more than 26 micromol/L or 25%) among patients ready to be discharged from the ICU or acute careTCU. and within 30 days after their 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)

Locations (1)

Hospital Lariboisière

Paris, France