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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
EU CTIS ID: 2024-515845-40-00
What this study is testing
To evaluate the impact of the RAASi on cardiovascular and global outcome during the year following ICU or Transitional Care Unit (TCU) discharge in patients who developed an AKI and totally or partially recovered
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female patients ≥ 18 years of age
- 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 TCU. and within 30 days after their discharge.
- 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.
You likely can't join if
- Patient treated with ACEi or ARB before ICU admission
- 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
- 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.
See the full eligibility criteria
- Male or female patients ≥ 18 years of age
- 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 TCU. and within 30 days after their discharge.
- 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.
- Patient treated with ACEi or ARB before ICU admission
- 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
- 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.
- Patients deprived of liberty by a judicial or administrative decision
- Patient to a legal protection measure (guardianship, curatorship and safeguard of justice)
- Patient for whom treatment with ACEi or ARA is strongly recommended according to the international guidelines (ie patients with congestive heart failure and persistent dyspnea with LVEF<40%, patients with diabetes mellitus AND [either albuminuria > 30mg /g creatininuria or hypertension associated with microalbuminuria or hypertension associated with eGFR < 60 ml/min) known before ICU admission
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.