Iohexol Clearance in Critically Ill Patients With Augmented Renal Creatinine Clearance
- Registration Number
- NCT04776486
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
Evaluation of glomerular filtration rate using iohexol plasma clearance in critically ill patients with augmented renal creatinine clearance
- Detailed Description
Single center study in ICU patients with augmented renal clearance comparing glomerular filtration rate (GFR) as measured by iohexol plasma clearance to that measured by creatinine clearance. Primary objective is to compare the GFR estimates made by iohexol plasma clearance (as reference method) and creatinine clearance using Bland-Altman method.
Secondary objective are to compare GFR as measured by iohexol plasma clearance to that calculated with the most commonly used renal clearance estimating formulas (Cockcroft and Gault, MDRD and CKD-EPI ), evaluate clinical determinant of the observed differences and evaluate determinants of extracellular volume.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- ICU patient
- 24h Creatinine clearance >130ml/min/1.73m2
- Urinary catheterization
- Affiliation to a social security scheme
- Pregnancy
- CT-scan with contrast media infusion the day of inclusion
- Documented allergy to contrast media
- Patient under guardianship / curatorship
- Patient benefiting from the "State Medical Assistance"
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Critically ill patients with augmented renal clearance Iohexol ICU patients with estimated renal clearance over 130ml/min/1.73m2
- Primary Outcome Measures
Name Time Method GFR obtained by the iohexol clearance technique 6 hours GFR as measured by iohexol plasma clearance to evaluate its concordance, by the Bland and Altman method, with that obtained by measuring the clearance of creatinine.
GFR obtained by the creatinine clearance technique 6 hours GFR as measured by creatinine plasma clearance
- Secondary Outcome Measures
Name Time Method Plasmatic Levetiracetam dosing 6 hours To detect underdosing and risk of therapeutic failure of Levetiracetam
Plasmatic Cefotaxim dosing 6 hours To detect underdosing and risk of therapeutic failure of Cefotaxim
GFR calculated using the Cockroft-Gault equation 6 hours Estimation of GFR using the Cockroft-Gault method based on the serum creatinine clearance measured on the day of intervention and the patient's weight of the day, and the agreement with the GFR measured by the iohexol clearance
GFR calculated using the Modification of diet in renal disease (MDRD) formula 6 hours Estimation of GFR using MDRD method based on the serum creatinine clearance measured on the day of intervention and the patient's weight of the day, and the agreement with the GFR measured by the iohexol clearance
GFR calculated using the Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) equation 6 hours Estimation of GFR using CKD-EPI method based on the serum creatinine clearance measured on the day of intervention and the patient's weight of the day, and the agreement with the GFR measured by the iohexol clearance
Plasmatic Vancomycin dosing 6 hours To detect underdosing and risk of therapeutic failure of Vancomycin
Plasmatic Piperacillin dosing 6 hours To detect underdosing and risk of therapeutic failure of Piperacillin
Plasmatic Aminoglycoside dosing 6 hours To detect underdosing and risk of therapeutic failure of Aminoglycoside
Trial Locations
- Locations (1)
Lariboisière Hospital, Surgical ICU
🇫🇷Paris, Ile De France, France