NCT02050269

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

December 22, 2025

Status Verified

October 1, 2016

Enrollment Period

2.4 years

First QC Date

January 28, 2014

Last Update Submit

December 15, 2025

Conditions

Acute Circulatory Failure

Outcome Measures

Primary Outcomes (1)

  • Plasma clearance of iohexol

    24 hours

Secondary Outcomes (5)

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

    7 days

  • Link between plasma iohexol clearance and kindney injury markers

    24 hours

  • Link between injury and/or functional kidney dammage and subsequent acute kidney injury

    7 days

  • Link between plasma iohexol clearance and urinary metabolomic markers

    24 hours

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

    24 hours

Study Arms (1)

Iohexol

EXPERIMENTAL

injection of 5 ml of iohexol

Drug: Iohexol

Interventions

IohexolDRUG

Iohexol, 300 mg/mL

Iohexol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Pregnancy or breastfeeding in progress
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital La SOURCE

Orléans, 45000, France

Location

University Hospital Strasbourg

Strasbourg, 67000, France

Location

Service de Réanimation Polyvalente, CHRU de Tours

Tours, 37044, France

Location

Related Publications (2)

  • 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.

    PMID: 27166722RESULT

  • 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.

    PMID: 33710029DERIVED

MeSH Terms

Conditions

Shock

Interventions

Iohexol

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triiodobenzoic AcidsIodobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Stephan EHRMANN, MCU-PH

    University Hospital, Tours

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2014

First Posted

January 30, 2014

Study Start

January 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

December 22, 2025

Record last verified: 2016-10

Locations

FR(3)