Clinical trial NCT04776486: Iohexol Clearance in Critically Ill Patients With Augmented Renal Creatinine Clearance
Official title: Evaluation of Glomerular Filtration Rate Using Iohexol Plasma Clearance in Critically Ill Patients With Augmented Renal Creatinine Clearance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Augmented Renal Clearance
Critically Ill
Keywords: Iohexol
Augmented renal clearance
Intensive Care Unit
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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"

Primary outcomes:
measure: GFR obtained by the iohexol clearance technique
timeFrame: 6 hours
measure: GFR obtained by the creatinine clearance technique
timeFrame: 6 hours
Secondary outcomes:
measure: GFR calculated using the Cockroft-Gault equation
timeFrame: 6 hours
measure: GFR calculated using the Modification of diet in renal disease (MDRD) formula
timeFrame: 6 hours
measure: GFR calculated using the Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) equation
timeFrame: 6 hours
measure: Plasmatic Levetiracetam dosing
timeFrame: 6 hours
measure: Plasmatic Vancomycin dosing
timeFrame: 6 hours
measure: Plasmatic Piperacillin dosing
timeFrame: 6 hours
measure: Plasmatic Cefotaxim dosing
timeFrame: 6 hours
measure: Plasmatic Aminoglycoside dosing
timeFrame: 6 hours
Other outcomes:
Locations:
city: Paris
country: France
facility: Lariboisière Hospital, Surgical ICU
state: Ile De France
Study officials:
affiliation: Lariboisière Hospital, APHP Nord
name: Benjamin G Chousterman, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salmon-Gandonniere C, Benz-de Bretagne I, Mercier E, Joret A, Halimi JM, Ehrmann S, Barin-Le Guellec C. Iohexol clearance in unstable critically ill patients: a tool to assess glomerular filtration rate. Clin Chem Lab Med. 2016 Nov 1;54(11):1777-1786. doi: 10.1515/cclm-2015-1202.