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
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.
As second objectives, the study aims to:
Patient with acute kidney injury during ICU stay
Exclusion Criteria:
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
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
Progression of the proteinuria
Evolution of urinary protein to creatinine ratio (mg/mmol).
Time frame: 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.
Time frame: 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.
Time frame: At 3 years
All-cause mortality
All-cause mortality and cardiovascular cause mortality
Time frame: 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).
Time frame: 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.
Time frame: At the end of 1 year
Cost
Costs related to medical care
Time frame: At 3 years
Plan to share: No
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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Assistance Publique - Hôpitaux de Paris