Clinical trial NCT03282409: Prediction of Chronic Renal Disease After Acute Kidney Injury in the Intensive Care Unit
Official title: Prediction of Chronic Renal Disease After Acute Kidney Injury in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Kidney Injury
Chronic Renal Disease
Keywords: Prediction
Chronic Renal Disease
Acute Kidney Injury
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2017-09-14
Enrollment: 425
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with acute kidney injury during ICU stay

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of chronic kidney disease
timeFrame: At 3 years
Secondary outcomes:
measure: Progression of chronic renal disease defined by the slope of GFR decline
timeFrame: At 3 years
measure: Progression of the proteinuria
timeFrame: At 3 years
measure: Progression of chronic renal disease defined by the number of patients with end-stage renal disease requiring dialysis or renal transplantation
timeFrame: At 3 years
measure: Occurrence of cardiovascular events and thromboembolic events
timeFrame: At 3 years
measure: All-cause mortality
timeFrame: At 3 years
measure: Quality of life assessment
timeFrame: At the end of 1 year
measure: Quality of life assessment
timeFrame: At the end of 1 year
measure: Cost
timeFrame: At 3 years
Other outcomes:
Locations:
city: Boulogne Billancourt
country: France
facility: Intensive care unit, Ambroise Pare Hospital
state: Hauts-de-seine
Study officials:
affiliation: Service de Réanimation médico-chirurgicale, Hôpital Ambroise Paré
name: Guillaume Geri, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service de Réanimation médico-chirurgicale, Hôpital Ambroise Paré
name: Antoine Vieillard Baron, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.