Prediction of Chronic Renal Disease After Acute Kidney Injury in the Intensive Care Unit

NCT ID: NCT03282409

Last Updated: 2025-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

425 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-26

Study Completion Date

2025-05-31

Brief Summary

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The study aims to develop and validate a prediction score of chronic renal disease occurrence within 3 years after ICU discharge in patients who suffered an acute kidney failure during ICU stay and recovered normal renal function at 90 days following their discharge.

The primary study outcome is the incidence of chronic renal disease within the first 3 years after ICU discharge, defined by a lower glomerular filtration rate (GFR) under 60 mL/minute/1.73m2.

Detailed Description

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As second objectives, the study aims to:

* Evaluate the GFR decline in patients who had an underlying chronic kidney disease.
* Evaluate factors associated with a persistent decreased GFR at day-90.
* Characterization the clinical and biological phenotype of chronic renal disease in these patients.
* Evaluate treatments provided to these patients according to CKD occurence.
* Evaluate the rate of cardiovascular and thrombo-embolic morbidity-mortality.
* Assess the quality of life every year for 3 years.
* Evaluate the medico-economic burden of CKD.

Conditions

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Acute Kidney Injury Chronic Renal Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patient ⩾ 18 years;
* Patient suffering an acute kidney injury (defined by AKIN score ⩾1) during ICU stay;
* Patient discharged alive from the ICU;
* Patient's signed consent obtained;
* Patient covered by a healthcare insurance.

Exclusion Criteria

* Pregnant or breastfeeding woman;
* SOFA score \< 1 (except for kidney assessment) at time of ICU admission;
* End-stage of renal failure or dialysis treatment or renal transplantation prior to ICU admission;
* Patient treated with dialysis at ICU discharge;
* Immunosuppressive treatment prior to ICU admission;
* Patient under legal incapacity (tutor or guardian protection);
* Being unable to follow-up of the study;
* Life expectancy expected shorter than 90 days;
* Refusal to participate in the study;
* Patient's main address is outside of Il de France region for the centers in this region;
* Patient \< 18 years;
* Patient not affiliated to national social security scheme;
* Patient deprived of liberty by judicial measure.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillaume Geri, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Service de Réanimation médico-chirurgicale, Hôpital Ambroise Paré

Antoine Vieillard Baron, MD, PhD

Role: STUDY_DIRECTOR

Service de Réanimation médico-chirurgicale, Hôpital Ambroise Paré

Locations

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Intensive care unit, Ambroise Pare Hospital

Boulogne-Billancourt, Hauts-de-seine, France

Site Status

Countries

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France

References

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de Roquetaillade C, Durand M, Beaucote V, Guillemin J, Chadjichristos CE, Roquilly A, Chousterman BG. Progression of Kidney Fibrosis after Sepsis: Underestimated Role of Resident Macrophages and Recruited Monocytes. J Am Soc Nephrol. 2025 Mar 28;36(7):1417-1427. doi: 10.1681/ASN.0000000712.

Reference Type DERIVED
PMID: 40152940 (View on PubMed)

Geri G, Stengel B, Jacquelinet C, Aegerter P, Massy ZA, Vieillard-Baron A; PREDICT investigators. Prediction of chronic kidney disease after acute kidney injury in ICU patients: study protocol for the PREDICT multicenter prospective observational study. Ann Intensive Care. 2018 Jul 6;8(1):77. doi: 10.1186/s13613-018-0421-7.

Reference Type DERIVED
PMID: 29980878 (View on PubMed)

Other Identifiers

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AOR16089

Identifier Type: -

Identifier Source: org_study_id

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