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

NCT ID: NCT02050269

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Circulatory Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Iohexol

injection of 5 ml of iohexol

Group Type EXPERIMENTAL

Iohexol

Intervention Type DRUG

Iohexol, 300 mg/mL

Interventions

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Iohexol

Iohexol, 300 mg/mL

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephan EHRMANN, MCU-PH

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Tours

Locations

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Hospital La SOURCE

Orléans, , France

Site Status

University Hospital Strasbourg

Strasbourg, , France

Site Status

Service de Réanimation Polyvalente, CHRU de Tours

Tours, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 27166722 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33710029 (View on PubMed)

Other Identifiers

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2013-003936-65

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2013-R49

Identifier Type: OTHER

Identifier Source: secondary_id

131229A-11

Identifier Type: OTHER

Identifier Source: secondary_id

PHAO13-SE / IoxRea

Identifier Type: -

Identifier Source: org_study_id