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

Primary Purpose

Acute Circulatory Failure

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Iohexol
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Circulatory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital La SOURCE
  • University Hospital Strasbourg
  • Service de Réanimation Polyvalente, CHRU de Tours

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Iohexol

Arm Description

injection of 5 ml of iohexol

Outcomes

Primary Outcome Measures

Plasma clearance of iohexol

Secondary Outcome Measures

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

Full Information

First Posted
January 28, 2014
Last Updated
October 24, 2016
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT02050269
Brief Title
Measuring the Plasma Clearance of Iohexol to Estimate Glomerular Filtration Rate in Intensive Care Unit Patients: Preliminary Feasibility Study
Acronym
IoxRea
Official Title
Measuring the Plasma Clearance of Iohexol to Estimate Glomerular Filtration Rate in Intensive Care Unit Patients: Preliminary Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Circulatory Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Iohexol
Arm Type
Experimental
Arm Description
injection of 5 ml of iohexol
Intervention Type
Drug
Intervention Name(s)
Iohexol
Intervention Description
Iohexol, 300 mg/mL
Primary Outcome Measure Information:
Title
Plasma clearance of iohexol
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Plasma clearance of iohexol in patients developping or not acute kidney injury
Time Frame
7 days
Title
Link between plasma iohexol clearance and kindney injury markers
Time Frame
24 hours
Title
Link between injury and/or functional kidney dammage and subsequent acute kidney injury
Time Frame
7 days
Title
Link between plasma iohexol clearance and urinary metabolomic markers
Time Frame
24 hours
Title
Comparaison of plasma iohexol clearance measured with 3 and 6 vs. 9 kinetic points
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan EHRMANN, MCU-PH
Organizational Affiliation
University Hospital, Tours
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital La SOURCE
City
Orleans
ZIP/Postal Code
45000
Country
France
Facility Name
University Hospital Strasbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Service de Réanimation Polyvalente, CHRU de Tours
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33710029
Citation
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.
Results Reference
derived

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

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