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

Acute Kidney Injury Clinical Trial

— PREDICT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03282409
• Other study ID #: AOR16089
• Status: Active, not recruiting
• Start date: April 26, 2018
• Est. completion date: February 2025

Study information

• Verified date: September 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 425
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Chronic Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic
• Wounds and Injuries

Locations

Country	Name	City	State
France	Intensive care unit, Ambroise Pare Hospital	Boulogne Billancourt	Hauts-de-seine

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Progression of the proteinuria	Evolution of urinary protein to creatinine ratio (mg/mmol).	At 3 years
Secondary	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
Secondary	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
Secondary	All-cause mortality	All-cause mortality and cardiovascular cause mortality	At 3 years
Secondary	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
Secondary	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
Secondary	Cost	Costs related to medical care	At 3 years