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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515845-40-00
Acronym
APHP 200040
Enrollment
508
Registered
2024-10-23
Start date
2022-11-22
Completion date
Unknown
Last updated
2024-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute kidney injury

Brief summary

The primary endpoint of the trial is the time to MACE (major adverse cardiovascular events), i.e. a composite outcome composed of all-cause mortality and all unscheduled hospital readmission for cardiovascular events (acute heart failure, stroke, acute coronary syndrome) during the year following ICU or TCU discharge

Detailed description

Albuminuria >0.3 g/day one year after ICU or TCU discharge, Occurrence of chronic kidney disease one year after ICU or TCU discharge defined as eGFR <60 ml/min/1.73m2, Decrease of estimated glomerular filtration from baseline to one year after enrollment, Change in Chronic kidney disease staging one year after enrollment, New episode of acute kidney injury (according to the KDIGO criteria) requiring hospitalization, Hyperkalemia >6 mmol/L, Death, Biological collection built up at inclusion and at the end of the study

Interventions

DRUGPlacebo IRBESARTAN EG 150 mg
DRUGIrbesartan EG 150 mg comprimés pelliculés

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint of the trial is the time to MACE (major adverse cardiovascular events), i.e. a composite outcome composed of all-cause mortality and all unscheduled hospital readmission for cardiovascular events (acute heart failure, stroke, acute coronary syndrome) during the year following ICU or TCU discharge

Secondary

MeasureTime frame
Albuminuria >0.3 g/day one year after ICU or TCU discharge, Occurrence of chronic kidney disease one year after ICU or TCU discharge defined as eGFR <60 ml/min/1.73m2, Decrease of estimated glomerular filtration from baseline to one year after enrollment, Change in Chronic kidney disease staging one year after enrollment, New episode of acute kidney injury (according to the KDIGO criteria) requiring hospitalization, Hyperkalemia >6 mmol/L, Death, Biological collection built up at inclusion and at the end of the study

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026