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

Active, not recruiting

• Conditions: Acute Kidney Injury; Chronic Renal Disease

• Registration Number: NCT03282409
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-07-31
• Study First Submitted QC: 2017-09-11
• Study First Posted: 2017-09-14
• Study Start: 2018-04-26
• Status Verified: 2025-03
• Primary Completion: 2025-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-06
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 425

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of chronic kidney disease	At 3 years	Incidence of chronic kidney disease defined by a decreased glomerular filtration rate (GFR) under 60 mL/minute/1.73m2.

Secondary Outcome Measures

Name	Time	Method
Progression of chronic renal disease defined by the number of patients with end-stage renal disease requiring dialysis or renal transplantation	At 3 years	For patients who have chronic renal disease history and developped an acute kidney failure during ICU stay, progression of chronic renal disease defined by need to dialysis, or need a renal transplantation, and GFR \< 15mL/minute/1.73m2.
All-cause mortality	At 3 years	All-cause mortality and cardiovascular cause mortality
Occurrence of cardiovascular events and thromboembolic events	At 3 years	Cardiovascular events include acute coronary syndrome, ischemic stroke, peripheral artery disease, ventricular rhythm disorder and sudden death.; Thromboembolic events included deep vein thrombosis and pulmonary embolism.
Progression of chronic renal disease defined by the slope of GFR decline	At 3 years	For patients who have chronic renal disease history and developped an acute kidney failure during ICU stay, progression of chronic renal disease defined by a GFR decline greater than 30% at 3 years.
Quality of life assessment	At the end of 1 year	Assessment of quality of life of patients by the scale EQ-5D-5L. The EQ-5D-5L questionnaire consists the descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state.
Cost	At 3 years	Costs related to medical care
Progression of the proteinuria	At 3 years	Evolution of urinary protein to creatinine ratio (mg/mmol).

Trial Locations

Locations (1)

Intensive care unit, Ambroise Pare Hospital; 🇫🇷 Boulogne Billancourt, Hauts-de-seine, France