Follow-up of Long-term Renal Function After Acute Kidney Injury in ICU

• Conditions: Acute Kidney Injuries; Renal Replacement Therapy; Chronic Kidney Disease; Quality of Life

• Registration Number: NCT03302624
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

Acute kidney injury (AKI) involves poor prognosis in ICU patients. The renal prognosis at long term is unknown.

The study will determine chronic kidney injury incidence and quality of life, five years after AK during ICU stay.

Detailed Description

Prospective study. All patients who participated ELVIS study (clinical trials: 00875069) can be enrolled in SURIA.

Patients are contacted by telephone. Investigator delivery objective and honest information. If patients accepts the study, answers will be collected.

Collected data are: creatinine serum, two surveys (quality of life and activities of daily living), date of onset of renal replacement therapy.

Study Timeline

• Study Start: 2017-09-01
• Status Verified: 2017-10
• Study First Submitted: 2017-10-02
• Study First Submitted QC: 2017-10-02
• Study First Posted: 2017-10-05
• Last Update Submitted: 2017-10-05
• Last Update Posted: 2017-10-06
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 506

Inclusion Criteria

ICU Patients included in ELVIS study, AKI requiring renal replacement therapy Length of ICU stay ≥ 48h

Exclusion Criteria

Pregnant or nursing woman's job

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of chronic kidney disease	5 years after the first acute kidney injury requiring renal replacement therapy	incidence of chronic kidney disease in patients who had an acute kidney injury during their ICU stay and requiring an renal replacement therapy

Secondary Outcome Measures

Name	Time	Method
Mortality	5 years after the first acute kidney injury requiring renal replacement therapy	Mortality
Activities of daily living	5 years after the first acute kidney injury requiring renal replacement therapy	Activities of daily living will be assessed with the Katz adjustment scales
severity of CKD according to the International Classification of Chronic Kidney Disease	5 years after the first acute kidney injury requiring renal replacement therapy	Kidney function will be measured by creatinine serum or chronic dialysis or kidney transplantation
impact of the renal replacement therapy on long-term renal function	5 years after the first acute kidney injury requiring renal replacement therapy	Intermittent or continuous renal replacement therapy. Data collected in the database from ELVIS study. Kidney function will be measured by creatinine serum or chronic dialysis
quality of life	5 years after the first acute kidney injury requiring renal replacement therapy	Quality of life will be assessed with the Q5D score

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France