Status:
ACTIVE_NOT_RECRUITING
Impact of a Treatment With Angiotensin Receptor Blocker on Outcome After Acute Kidney Injury in Patients Discharged From the ICU.
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Acute Kidney Injury
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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, p...
Detailed Description
Phase III study Prospective, multicenter, superiority, double-blind, randomized controlled study with two arms (1:1). * Inclusion of patients who are discharged alive (or ready to be discharged) from...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 27 2026
Estimated Enrollment :
508 Patients enrolled
Trial Details
Trial ID
NCT05272878
Start Date
November 22 2022
End Date
June 27 2026
Last Update
September 8 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Lariboisière
Paris, France, 75010