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Active, not recruitingNCT03282409PREDICTUpdated Apr 6, 2025

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

An observational study in Acute Kidney Injury and Chronic Renal Disease, sponsored by Assistance Publique - Hôpitaux de Paris. Active, not recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-06.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
425
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Acute Kidney Injury
  • Chronic Renal Disease

Keywords

  • Prediction
  • Chronic Renal Disease
  • Acute Kidney Injury
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patient with acute kidney injury during ICU stay

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
425 participants (actual)
Patient registry
No
05

What researchers measure

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.

    Time frame: At 3 years

Secondary outcomes

  1. Progression of chronic renal disease defined by the slope of GFR decline

    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.

    Time frame: At 3 years

  2. Progression of the proteinuria

    Evolution of urinary protein to creatinine ratio (mg/mmol).

    Time frame: At 3 years

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

    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.

    Time frame: At 3 years

  4. Occurrence of cardiovascular events and thromboembolic events

    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.

    Time frame: At 3 years

  5. All-cause mortality

    All-cause mortality and cardiovascular cause mortality

    Time frame: At 3 years

  6. Quality of life assessment

    Assessment of quality of life of patients by the scale KDQOL-SF-12. The SF-12 is a short form that includes Items 1-12 as generic core of kidney Disease Quality of Life Instrument (KDQOL).

    Time frame: At the end of 1 year

  7. Quality of life assessment

    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.

    Time frame: At the end of 1 year

  8. Cost

    Costs related to medical care

    Time frame: At 3 years

06

Study locations

1 site
  • Intensive care unit, Ambroise Pare Hospital
    Boulogne Billancourt, Hauts-de-seine 92100, France
07

References and documents

Publications

  • 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. PubMed 29980878 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03282409
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Sep 14, 2017
Start date
Apr 26, 2018
Primary completion
Apr 2025 (estimated)
Completion
May 2025 (estimated)
Last update
Apr 6, 2025

Study contacts

Guillaume Geri, MD, PhD
principal investigator · Service de Réanimation médico-chirurgicale, Hôpital Ambroise Paré
Antoine Vieillard Baron, MD, PhD
study director · Service de Réanimation médico-chirurgicale, Hôpital Ambroise Paré

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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