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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03282409

Acronym

PREDICT

Enrollment

425

Registered

2017-09-14

Start date

2018-04-26

Completion date

2025-05-31

Last updated

2025-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Chronic Renal Disease

Keywords

Prediction, Chronic Renal Disease, Acute Kidney Injury

Brief 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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Progression of the proteinuria	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	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	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.
Progression of chronic renal disease defined by the slope of GFR decline	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.
Quality of life assessment	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).
Cost	At 3 years	Costs related to medical care
All-cause mortality	At 3 years	All-cause mortality and cardiovascular cause mortality

Countries

France

Outcome results