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

• Sponsor: University Hospital, Tours (Other)
• Overall Status: Completed
• CT.gov ID: NCT02050269
• Collaborator: (none)
• Enrollment: 100
• Locations: 3
• Arm: 1
• Duration (Months): 29
• Patients Per Site: 33.3
• Patients Per Site Per Month: 1.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Circulatory Failure	Drug: Iohexol	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Measuring the Plasma Clearance of Iohexol to Estimate Glomerular Filtration Rate in Intensive Care Unit Patients: Preliminary Feasibility Study
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Iohexol injection of 5 ml of iohexol	Drug: Iohexol; Iohexol, 300 mg/mL

Outcome Measures

Primary Outcome Measures

1. Plasma clearance of iohexol [24 hours]

Secondary Outcome Measures

1. Plasma clearance of iohexol in patients developping or not acute kidney injury [7 days]

2. Link between plasma iohexol clearance and kindney injury markers [24 hours]

3. Link between injury and/or functional kidney dammage and subsequent acute kidney injury [7 days]

4. Link between plasma iohexol clearance and urinary metabolomic markers [24 hours]

5. Comparaison of plasma iohexol clearance measured with 3 and 6 vs. 9 kinetic points [24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital La SOURCE	Orleans		France	45000
2	University Hospital Strasbourg	Strasbourg		France	67000
3	Service de Réanimation Polyvalente, CHRU de Tours	Tours		France	37044

Sponsors and Collaborators

• University Hospital, Tours

Investigators

• Principal Investigator: Stephan EHRMANN, MCU-PH, University Hospital, Tours

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Tours
• ClinicalTrials.gov Identifier: NCT02050269
• Other Study ID Numbers: PHAO13-SE / IoxRea; 2013-003936-65; 2013-R49; 131229A-11
• First Posted: Jan 30, 2014
• Last Update Posted: Oct 25, 2016
• Last Verified: Oct 1, 2016

• Additional relevant MeSH terms: Shock

Study Results

No Results Posted as of Oct 25, 2016