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NCT Number: NCT03282409

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

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

    Time frame: 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.

  2. Progression of the proteinuria

    Time frame: At 3 years

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

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

    Time frame: 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.

  4. Occurrence of cardiovascular events and thromboembolic events

    Time frame: 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.

  5. All-cause mortality

    Time frame: At 3 years

    All-cause mortality and cardiovascular cause mortality

  6. Quality of life assessment

    Time frame: At the end of 1 year

    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).

  7. Quality of life assessment

    Time frame: 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.

  8. Cost

    Time frame: At 3 years

    Costs related to medical care

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: PREDICT

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Sep 14, 2017
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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