DETECTION OF ACUTE RENAL FAILURE IN CRITICALLY ILL PATIENTS: A prospective evaluation of cystatin C diagnostic performance

• Conditions: critically ill patients hospitalised in inetnsive care unit; MedDRA version: 13.1Level: PTClassification code 10022519Term: Intensive careSystem Organ Class: 10042613 - Surgical and medical procedures

• Registration Number: EUCTR2009-010190-20-FR
• Lead Sponsor: CHU Saint-Etienne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

- 18 to 75 years
- patients hospitalized in intensive care unit for at least 72 h with the admission score IGS> 2
- patient intubated-ventilated and stable in respiratory
- haemodynamically stable patient
- patient with indwelling catheter and central venous catheter, and peripheral catheter
- last rate of plasma creatinine <2.5mg/dl

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- allergic patient
- patients with severe hepatic impairment defined as a TP spontaneously below 50%
Patients with a history of dysthyroidism
- Patient requiring treatment with trimethoprim, cimetidine or corticosteroid (inflammatory dose)
- Pregnant or lactating

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: to evaluate urinary biomarkers NGAL, IL 8 et KIM-1 in relation to a gold standard method of glomerular filtration rate measurement;Primary end point(s): - Area under the curve ROC for a threshold of iohexol clearance of 60 ml / min of cystatin C and plasma creatinin.;Main Objective: to evaluate the diagnostic performance of cystatin C to detect renal failure in critically ill patients, the true level of renal function impairment being determined by a gold standard method of glomerular filtration rate measurement.