Iohexol Clearance in Critically Ill Patients With Augmented Renal Creatinine Clearance (GFR-ARC)

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

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

Study Overview

• Status: Recruiting
• Conditions: Critically Ill; Augmented Renal Clearance
• Intervention / Treatment: Drug: Iohexol

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Magalie Collet, MD; Phone Number: +33 (0)149958515; Email: magalie.collet@aphp.fr

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 75010
      • Recruiting
      • Lariboisière Hospital, Surgical ICU
      • Contact: Magalie Collet, MD; Phone Number: +33 (0)149958515; Email: magalie.collet@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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"

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Critically ill patients with augmented renal clearance; ICU patients with estimated renal clearance over 130ml/min/1.73m2	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.; Other Names: Omnipaque

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
GFR obtained by the creatinine clearance technique	GFR as measured by creatinine plasma clearance	6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Plasmatic Levetiracetam dosing	To detect underdosing and risk of therapeutic failure of Levetiracetam	6 hours
Plasmatic Vancomycin dosing	To detect underdosing and risk of therapeutic failure of Vancomycin	6 hours
Plasmatic Piperacillin dosing	To detect underdosing and risk of therapeutic failure of Piperacillin	6 hours
Plasmatic Cefotaxim dosing	To detect underdosing and risk of therapeutic failure of Cefotaxim	6 hours
Plasmatic Aminoglycoside dosing	To detect underdosing and risk of therapeutic failure of Aminoglycoside	6 hours

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Benjamin G Chousterman, MD PhD, Lariboisière Hospital, APHP Nord

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2020
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: July 17, 2020
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: January 1, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Iohexol; Intensive Care Unit; Augmented renal clearance
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: APHP190414; 2019-A00654-53 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No