Measuring the Plasma Clearance of Iohexol to Estimate Glomerular Filtration Rate in Intensive Care Unit Patients: Preliminary Feasibility Study (IoxRea)

December 15, 2025 updated by: University Hospital, Tours
The objective of this study is to assess the feasibility of estimating the clearance of iohexol as an indirect measure of glomerular filtration rate in patients with unstable renal function in the intensive care unit through analysis of rich iohexol plasma kinetics.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Orléans, France, 45000
        • Hospital La SOURCE
      • Strasbourg, France, 67000
        • University Hospital Strasbourg
      • Tours, France, 37044
        • Service de Réanimation Polyvalente, CHRU de Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Patient admitted to intensive care for less than 12 hours
  • Acute circulatory failure
  • Patient carrying an arterial catheter
  • Informed consent obtained
  • Affiliated to social security system

Exclusion Criteria:

  • Administration of iohexol the week before intensive care admission
  • Administration of iohexol expected within 24 hours of study entry
  • Known history of cutaneous immediate or delayed allergic reaction to the injection of the product
  • Indication for albumin transfusion within 24 hours of potential inclusion in the study
  • Pregnancy or breastfeeding in progress
  • Patient under guardianship or judicial protection known at the time of inclusion
  • Withdrawal of consent
  • Administration of iohexol outside the study within 24 hours after administration of iohexol in the context of the study
  • Administration of intravenous albumin in the 24 hours following administration of iohexol in the context of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Iohexol
injection of 5 ml of iohexol
Drug: Iohexol
Iohexol, 300 mg/mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma clearance of iohexol
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma clearance of iohexol in patients developping or not acute kidney injury
Time Frame: 7 days
7 days
Link between plasma iohexol clearance and kindney injury markers
Time Frame: 24 hours
24 hours
Link between injury and/or functional kidney dammage and subsequent acute kidney injury
Time Frame: 7 days
7 days
Link between plasma iohexol clearance and urinary metabolomic markers
Time Frame: 24 hours
24 hours
Comparaison of plasma iohexol clearance measured with 3 and 6 vs. 9 kinetic points
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Principal Investigator: Stephan EHRMANN, MCU-PH, University Hospital, Tours

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

January 28, 2014

First Submitted That Met QC Criteria

January 28, 2014

First Posted (Estimated)

January 30, 2014

Study Record Updates

Last Update Posted (Estimated)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHAO13-SE / IoxRea
  • 2013-003936-65 (EudraCT Number)
  • 2013-R49 (Other Identifier: CPP)
  • 131229A-11 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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