Augmented Renal Clearance, Critically Ill
Conditions
Keywords
Iohexol, Augmented renal clearance, Intensive Care Unit
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.
Interventions
DRUGIohexol
Intravenous injection of 5 ml of iohexol (Omnipaque) to calculate the glomerular filtration rate (area under the curve). Blood samples (2 ml) and urine (2 ml minimum) are to be collected for the determination of iohexol clearance at the following time points: pre-dose, 5 minutes, and 1, 2, 3, 4, 5, 6 hours post dose.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ICU patient * 24h Creatinine clearance \>130ml/min/1.73m2 * Urinary catheterization * Affiliation to a social security scheme
Exclusion criteria
* 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"
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GFR obtained by the creatinine clearance technique | 6 hours | GFR as measured by creatinine plasma clearance |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasmatic Piperacillin dosing | 6 hours | To detect underdosing and risk of therapeutic failure of Piperacillin |
| Plasmatic Cefotaxim dosing | 6 hours | To detect underdosing and risk of therapeutic failure of Cefotaxim |
| Plasmatic Aminoglycoside dosing | 6 hours | To detect underdosing and risk of therapeutic failure of Aminoglycoside |
| 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 |
| Plasmatic Levetiracetam dosing | 6 hours | To detect underdosing and risk of therapeutic failure of Levetiracetam |
| 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORBenjamin G Chousterman, MD PhD
Lariboisière Hospital, APHP Nord
Outcome results
None listed