Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
novembre 2022
juin 2026
04 septembre 2025
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.
Etablissements
Critères
Tous
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.
- 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.
- 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)