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

Acute Circulatory Failure Clinical Trial

— IoxRea  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02050269
• Other study ID #: PHAO13-SE / IoxRea
• Secondary ID: 2013-003936-6520
• Status: Completed
• Phase: Phase 3
• First received: January 28, 2014
• Last updated: October 24, 2016
• Start date: January 2014
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: ANSM - Agence national de sécurité du médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Circulatory Failure
• Shock

Intervention

Drug:
• Iohexol
Iohexol, 300 mg/mL

Locations

Country	Name	City	State
France	Hospital La SOURCE	Orleans
France	University Hospital Strasbourg	Strasbourg
France	Service de Réanimation Polyvalente, CHRU de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma clearance of iohexol		24 hours	No
Secondary	Plasma clearance of iohexol in patients developping or not acute kidney injury		7 days	No
Secondary	Link between plasma iohexol clearance and kindney injury markers		24 hours	No
Secondary	Link between injury and/or functional kidney dammage and subsequent acute kidney injury		7 days	No
Secondary	Link between plasma iohexol clearance and urinary metabolomic markers		24 hours	No
Secondary	Comparaison of plasma iohexol clearance measured with 3 and 6 vs. 9 kinetic points		24 hours	No