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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Kidney Injury, Chronic Renal Disease

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of chronic kidney disease | Incidence of chronic kidney disease defined by a decreased glomerular filtration rate (GFR) under 60 mL/minute/1.73m2. | At 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 3 years | 
| Progression of the proteinuria | Evolution of urinary protein to creatinine ratio (mg/mmol). | At 3 years | 
| 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. | At 3 years | 
| 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. | At 3 years | 
| All-cause mortality | All-cause mortality and cardiovascular cause mortality | At 3 years | 
| 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). | At the end of 1 year | 
| 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. | At the end of 1 year | 
| Cost | Costs related to medical care | At 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prediction, Chronic Renal Disease, Acute Kidney Injury