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CompletedNCT02050269IoxReaUpdated Dec 22, 2025

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

A Phase 3 interventional study of Iohexol in Acute Circulatory Failure, sponsored by University Hospital, Tours. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-22.

Sponsored by University Hospital, Tours · Phase 3, Interventional, and Diagnostic

Phase
Phase 3
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Acute Circulatory Failure

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03

In context

Shock

916 studies on the registry are indexed under Shock; 176 are open to participants now.

This study's enrollment of 100 is above the median of 77 across 540 interventional studies indexed under Shock.

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Lead sponsor

University Hospital, Tours is the lead sponsor of 304 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Iohexol

    injection of 5 ml of iohexol

    Drug: Iohexol

Interventions

  • DrugIohexol

    Iohexol, 300 mg/mL

06

What researchers measure

Primary outcomes

  1. Plasma clearance of iohexol

    Time frame: 24 hours

Secondary outcomes

  1. Plasma clearance of iohexol in patients developping or not acute kidney injury

    Time frame: 7 days

  2. Link between plasma iohexol clearance and kindney injury markers

    Time frame: 24 hours

  3. Link between injury and/or functional kidney dammage and subsequent acute kidney injury

    Time frame: 7 days

  4. Link between plasma iohexol clearance and urinary metabolomic markers

    Time frame: 24 hours

  5. Comparaison of plasma iohexol clearance measured with 3 and 6 vs. 9 kinetic points

    Time frame: 24 hours

07

Study locations

3 sites
  • Hospital La SOURCE
    Orléans, 45000, France
  • University Hospital Strasbourg
    Strasbourg, 67000, France
  • Service de Réanimation Polyvalente, CHRU de Tours
    Tours, 37044, France
08

References and documents

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. PubMed 27166722 ↗
  • Desgrouas M, Merdji H, Bretagnol A, Barin-Le Guellec C, Halimi JM, Ehrmann S, Salmon Gandonniere C. Kinetic Glomerular Filtration Rate Equations in Patients With Shock: Comparison With the Iohexol-Based Gold-Standard Method. Crit Care Med. 2021 Aug 1;49(8):e761-e770. doi: 10.1097/CCM.0000000000004946. PubMed 33710029 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02050269
Lead sponsor
University Hospital, Tours
Responsible party
Sponsor
First posted
Jan 30, 2014
Start date
Jan 2014
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Dec 22, 2025

Study contacts

Stephan EHRMANN, MCU-PH
principal investigator · University Hospital, Tours

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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