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Clinical Trials/NCT03282409
NCT03282409
Active, not recruiting
Not Applicable

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

Assistance Publique - Hôpitaux de Paris1 site in 1 country425 target enrollmentApril 26, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Kidney Injury
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
425
Locations
1
Primary Endpoint
Incidence of chronic kidney disease
Status
Active, not recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 26, 2018
End Date
May 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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;

Outcomes

Primary Outcomes

Incidence of chronic kidney disease

Time Frame: At 3 years

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

Secondary Outcomes

  • Progression of chronic renal disease defined by the slope of GFR decline(At 3 years)
  • All-cause mortality(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)
  • Quality of life assessment(At the end of 1 year)
  • Cost(At 3 years)
  • Progression of the proteinuria(At 3 years)
  • Occurrence of cardiovascular events and thromboembolic events(At 3 years)

Study Sites (1)

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