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

A

Assistance Publique - Hôpitaux de Paris

Status

Active, not recruiting

Conditions

Chronic Renal Disease
Acute Kidney Injury

Study type

Observational

Funder types

Other

Identifiers

NCT03282409
AOR16089

Details and patient eligibility

About

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.

Full 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.

Enrollment

425 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Central trial contact

Guillaume Geri, MD, PhD; Antoine Vieillard Baron, MD, PhD

Data sourced from clinicaltrials.gov

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