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Completed

NCT Number: NCT04776486

Iohexol 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

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Key information

Conditions

Augmented Renal Clearance Critical Illness Critically Ill Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lariboisière Hospital, Surgical ICU

Paris, Île-de-France Region, 75010, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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"

Treatment and study plan

Iohexol

Drug

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

Primary outcomes

  1. GFR obtained by the iohexol clearance technique

    Time frame: 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.

  2. GFR obtained by the creatinine clearance technique

    Time frame: 6 hours

    GFR as measured by creatinine plasma clearance

Secondary outcomes

  1. GFR calculated using the Cockroft-Gault equation

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

  4. Plasmatic Levetiracetam dosing

    Time frame: 6 hours

    To detect underdosing and risk of therapeutic failure of Levetiracetam

  5. Plasmatic Vancomycin dosing

    Time frame: 6 hours

    To detect underdosing and risk of therapeutic failure of Vancomycin

  6. Plasmatic Piperacillin dosing

    Time frame: 6 hours

    To detect underdosing and risk of therapeutic failure of Piperacillin

  7. Plasmatic Cefotaxim dosing

    Time frame: 6 hours

    To detect underdosing and risk of therapeutic failure of Cefotaxim

  8. Plasmatic Aminoglycoside dosing

    Time frame: 6 hours

    To detect underdosing and risk of therapeutic failure of Aminoglycoside

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: GFR-ARC

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Mar 1, 2021
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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