Iohexol Clearance in Critically Ill Patients With Augmented Renal Creatinine Clearance

Critically Ill Clinical Trial

— GFR-ARC  

Official title:

Evaluation of Glomerular Filtration Rate Using Iohexol Plasma Clearance in Critically Ill Patients With Augmented Renal Creatinine Clearance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04776486
• Other study ID #: APHP190414
• Secondary ID: 2019-A00654-53
• Status: Recruiting
• Phase: N/A
• Start date: September 3, 2020
• Est. completion date: March 2024

Study information

• Verified date: January 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Magalie Collet, MD
• Phone: +33 (0)149958515
• Email: magalie.collet[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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"

Related Conditions & MeSH terms

• Augmented Renal Clearance
• Critical Illness
• Critically Ill

Intervention

Drug:
• Iohexol
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.

Locations

Country	Name	City	State
France	Lariboisière Hospital, Surgical ICU	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 hours
Primary	GFR obtained by the creatinine clearance technique	GFR as measured by creatinine plasma clearance	6 hours
Secondary	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	6 hours
Secondary	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	6 hours
Secondary	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	6 hours
Secondary	Plasmatic Levetiracetam dosing	To detect underdosing and risk of therapeutic failure of Levetiracetam	6 hours
Secondary	Plasmatic Vancomycin dosing	To detect underdosing and risk of therapeutic failure of Vancomycin	6 hours
Secondary	Plasmatic Piperacillin dosing	To detect underdosing and risk of therapeutic failure of Piperacillin	6 hours
Secondary	Plasmatic Cefotaxim dosing	To detect underdosing and risk of therapeutic failure of Cefotaxim	6 hours
Secondary	Plasmatic Aminoglycoside dosing	To detect underdosing and risk of therapeutic failure of Aminoglycoside	6 hours