Effect of Angiotensin Receptor Blocker on Recovery After Acute Kidney Injury in ICU Patients
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
This study is testing if the medication Irbesartan can help ICU patients recover better and reduce heart problems after they have had acute kidney injury.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 508 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05272878 on ClinicalTrials.gov |
What this trial studies
This Phase III clinical trial investigates the impact of the angiotensin receptor blocker Irbesartan on long-term outcomes in patients who have experienced acute kidney injury (AKI) during their stay in the intensive care unit (ICU). The study involves a multicenter, double-blind, randomized controlled design, where eligible patients will be assigned to receive either Irbesartan or a placebo after their renal function stabilizes. Participants will undergo regular clinical examinations and biological assessments over a 12-month period to evaluate cardiovascular health and kidney function. The goal is to determine if treatment with Irbesartan can reduce the risk of cardiovascular events and improve overall prognosis for post-AKI ICU survivors.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 who have developed acute kidney injury during their ICU stay and are ready for discharge.
Not a fit: Patients who were treated with ACE inhibitors or angiotensin receptor blockers prior to ICU admission may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve long-term cardiovascular outcomes for patients recovering from acute kidney injury.
How similar studies have performed: Previous observational studies have suggested potential benefits of RAAS inhibitors in similar patient populations, but this approach is being rigorously tested in a controlled setting.
Eligibility criteria
Show full inclusion / exclusion 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 (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)
Where this trial is running
Paris
- Hospital Lariboisière — Paris, France (Recruiting)
Study contacts
- Principal investigator: Etienne Gayat, MD-PhD — APHP-Hôpital Lariboisière
- Study coordinator: Etienne GAYAT, MD-PhD
- Email: etienne.gayat@aphp.fr
- Phone: 01 49 95 80 84
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.