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

NCT03282409 | Active Not Recruiting

• 1 other identifier: AOR16089
• Study Type: observational
• Target: 425
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Kidney Injury; Chronic Renal Disease

Keywords

Prediction; Chronic Renal Disease; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Incidence of chronic kidney disease

  Incidence of chronic kidney disease defined by a decreased glomerular filtration rate (GFR) under 60 mL/minute/1.73m2.

  At 3 years

Secondary Outcomes (8)

• Progression of chronic renal disease defined by the slope of GFR decline

  At 3 years

• Progression of the proteinuria

  At 3 years

• Progression of chronic renal disease defined by the number of patients with end-stage renal disease requiring dialysis or renal transplantation

  At 3 years

• Occurrence of cardiovascular events and thromboembolic events

  At 3 years

• All-cause mortality

  At 3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with acute kidney injury during ICU stay

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Intensive care unit, Ambroise Pare Hospital

Boulogne-Billancourt, Hauts-de-seine, 92100, France

Location

Related Publications (2)

• 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.

  PMID: 40152940 DERIVED

• 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.

  PMID: 29980878 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guillaume Geri, MD, PhD

  Service de Réanimation médico-chirurgicale, Hôpital Ambroise Paré

  PRINCIPAL INVESTIGATOR

• Antoine Vieillard Baron, MD, PhD

  Service de Réanimation médico-chirurgicale, Hôpital Ambroise Paré

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: September 14, 2017
• Study Start: April 26, 2018
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)