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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-010190-20-FR
Enrollment
Unknown
Registered
2009-04-06
Start date
2009-04-22
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

critically ill patients hospitalised in inetnsive care unit MedDRA version: 13.1 Level: PT Classification code 10022519 Term: Intensive care System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: OMNIPAQUE Product Name: OMNIPAQUE Pharmaceutical Form: Injection INN or Proposed INN: iohexol

Sponsors

CHU Saint-Etienne
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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 =65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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.

Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026