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

Phase 3

Completed

• Conditions: Acute Circulatory Failure
• Interventions: Drug: Iohexol

• Registration Number: NCT02050269
• Lead Sponsor: University Hospital, Tours

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-28
• Study First Submitted QC: 2014-01-28
• Study First Posted: 2014-01-30
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Iohexol	Iohexol	injection of 5 ml of iohexol

Primary Outcome Measures

Name	Time	Method
Plasma clearance of iohexol	24 hours

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Service de Réanimation Polyvalente, CHRU de Tours; 🇫🇷 Tours, France

University Hospital Strasbourg; 🇫🇷 Strasbourg, France

Hospital La SOURCE; 🇫🇷 Orleans, France