Prediction of Chronic Renal Disease After Acute Kidney Injury in the Intensive Care Unit (PREDICT)
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|ClinicalTrials.gov Identifier: NCT03282409|
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : July 2, 2019
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.
|Condition or disease|
|Acute Kidney Injury Chronic Renal Disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||1200 participants|
|Official Title:||Prediction of Chronic Renal Disease After Acute Kidney Injury in the Intensive Care Unit|
|Actual Study Start Date :||April 26, 2018|
|Estimated Primary Completion Date :||February 2023|
|Estimated Study Completion Date :||February 2023|
- 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.
- 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.
- Progression of the proteinuria [ Time Frame: At 3 years ]Evolution of urinary protein to creatinine ratio (mg/mmol).
- 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.
- 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.
- All-cause mortality [ Time Frame: At 3 years ]All-cause mortality and cardiovascular cause mortality
- 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).
- 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.
- Cost [ Time Frame: At 3 years ]Costs related to medical care
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282409
|Contact: Guillaume Geri, MD||+33 1 49 09 56 firstname.lastname@example.org|
|Contact: Antoine Vieillard Baron, MD, PhD||+33 1 49 09 56 email@example.com|
|Intensive care unit, Ambroise Pare Hospital||Recruiting|
|Boulogne Billancourt, Hauts-de-seine, France, 92100|
|Contact: Guillaume Geri, MD +331 49 09 56 05 firstname.lastname@example.org|
|Principal Investigator:||Guillaume Geri, MD||Service de Réanimation médico-chirurgicale, Hôpital Ambroise Paré|
|Study Director:||Antoine Vieillard Baron, MD, PhD||Service de Réanimation médico-chirurgicale, Hôpital Ambroise Paré|