Iohexol Clearance in Critically Ill Patients With Augmented Renal Creatinine Clearance

Assistance Publique - Hôpitaux de Paris90 enrolled

Overview

Evaluation of glomerular filtration rate using iohexol plasma clearance in critically ill patients with augmented renal creatinine clearance

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Augmented Renal Clearance Critically Ill

Interventions

IohexolDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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"

Locations (1)

Lariboisière Hospital, Surgical ICU

Paris, Île-de-France Region, France

Outcomes

Primary Outcomes

GFR obtained by the iohexol clearance technique

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.

Time frame: 6 hours

GFR obtained by the creatinine clearance technique

GFR as measured by creatinine plasma clearance

Time frame: 6 hours

Secondary Outcomes

GFR calculated using the Cockroft-Gault equation

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

Time frame: 6 hours

GFR calculated using the Modification of diet in renal disease (MDRD) formula

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

Time frame: 6 hours

GFR calculated using the Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) equation

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

Time frame: 6 hours

Plasmatic Levetiracetam dosing

To detect underdosing and risk of therapeutic failure of Levetiracetam

Time frame: 6 hours

Data from ClinicalTrials.gov

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