Clinical trial NCT02050269: Measuring the Plasma Clearance of Iohexol to Estimate Glomerular Filtration Rate in Intensive Care Unit Patients: Preliminary Feasibility Study
Official title: Measuring the Plasma Clearance of Iohexol to Estimate Glomerular Filtration Rate in Intensive Care Unit Patients: Preliminary Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Circulatory Failure
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2014-01-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Plasma clearance of iohexol
timeFrame: 24 hours
Secondary outcomes:
measure: Plasma clearance of iohexol in patients developping or not acute kidney injury
timeFrame: 7 days
measure: Link between plasma iohexol clearance and kindney injury markers
timeFrame: 24 hours
measure: Link between injury and/or functional kidney dammage and subsequent acute kidney injury
timeFrame: 7 days
measure: Link between plasma iohexol clearance and urinary metabolomic markers
timeFrame: 24 hours
measure: Comparaison of plasma iohexol clearance measured with 3 and 6 vs. 9 kinetic points
timeFrame: 24 hours
Other outcomes:
Locations:
city: Orleans
country: France
facility: Hospital La SOURCE
city: Strasbourg
country: France
facility: University Hospital Strasbourg
city: Tours
country: France
facility: Service de Réanimation Polyvalente, CHRU de Tours
Study officials:
affiliation: University Hospital, Tours
name: Stephan EHRMANN, MCU-PH
role: PRINCIPAL_INVESTIGATOR
References:
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.