Acute Circulatory FailurePhase 3IoxReaNCT02050269
Measuring the Plasma Clearance of Iohexol to Estimate Glomerular Filtration Rate in Intensive Care Unit Patients: Preliminary Feasibility Study
A Phase 3 study testing Iohexol in people with Acute Circulatory Failure, run by University Hospital, Tours at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Circulatory Failure
- What is being tested?
- Iohexol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesFrance
- Study dates
- Jan 2014to Jun 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hospital La SOURCE
Orléans, 45000
University Hospital Strasbourg
Strasbourg, 67000
Service de Réanimation Polyvalente, CHRU de Tours
Tours, 37044
About this study
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.
- Conditions
- Acute Circulatory Failure
- Being tested
- Iohexol
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IohexolDrug
Iohexol, 300 mg/mL
| Study group | Role | What they receive |
|---|---|---|
| Iohexol | Experimental | injection of 5 ml of iohexol Receives: Drug: Iohexol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma clearance of iohexol
Measured: 24 hours
Secondary outcomes (5)
Plasma clearance of iohexol in patients developping or not acute kidney injury
Measured: 7 days
Link between plasma iohexol clearance and kindney injury markers
Measured: 24 hours
Link between injury and/or functional kidney dammage and subsequent acute kidney injury
Measured: 7 days
Link between plasma iohexol clearance and urinary metabolomic markers
Measured: 24 hours
Comparaison of plasma iohexol clearance measured with 3 and 6 vs. 9 kinetic points
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Circulatory FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan EHRMANN, MCU-PH, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050269
- Sponsor's protocol ID
- PHAO13-SE / IoxRea
- Other IDs
- 2013-003936-65, 2013-R49, 131229A-11
- Acronym
- IoxRea
- Status last verified
- Oct 2016
- First submitted
- 28 Jan 2014
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Salmon-Gandonniere C, Benz-de Bretagne I, Mercier E, Joret A, Halimi JM, Ehrmann S, Barin-Le Guellec C. Iohexol clearance in unstable critically ill patients: a tool to assess glomerular filtration rate. Clin Chem Lab Med. 2016 Nov 1;54(11):1777-1786. doi: 10.1515/cclm-2015-1202.
PubMed 27166722Desgrouas 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.
PubMed 33710029
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Plasma Clearance of Iohexol to Estimate Glomerular Filtration Rate in Intensive Care Unit Patients: Preliminary Feasibility Study
- ClinicalTrials.gov ID
- NCT02050269
- Acronym / sponsor ID
- IoxRea / PHAO13-SE / IoxRea
- Conditions
- Acute Circulatory Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 30 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iohexol | Experimental | Drug: Iohexolinjection of 5 ml of iohexol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Patient admitted to intensive care for less than 12 hours
- Acute circulatory failure
- Patient carrying an arterial catheter
- Informed consent obtained
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IohexolIohexol, 300 mg/mL | Drug | Iohexol |
Primary outcome
Plasma clearance of iohexol
Time frame: 24 hours
5 secondary outcomes
Plasma clearance of iohexol in patients developping or not acute kidney injury
Time frame: 7 days
Link between plasma iohexol clearance and kindney injury markers
Time frame: 24 hours
Link between injury and/or functional kidney dammage and subsequent acute kidney injury
Time frame: 7 days
Link between plasma iohexol clearance and urinary metabolomic markers
Time frame: 24 hours
Comparaison of plasma iohexol clearance measured with 3 and 6 vs. 9 kinetic points
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 27166722Salmon-Gandonniere C, Benz-de Bretagne I, Mercier E, Joret A, Halimi JM, Ehrmann S, Barin-Le Guellec C. Iohexol clearance in unstable critically ill patients: a tool to assess glomerular filtration rate. Clin Chem Lab Med. 2016 Nov 1;54(11):1777-1786. doi: 10.1515/cclm-2015-1202.
- Derived from this study: PubMed 33710029Desgrouas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan EHRMANN, MCU-PH principal investigator
University Hospital, Tours
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Iohexol in people with Acute Circulatory Failure, run by University Hospital, Tours at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma clearance of iohexol (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02050269, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.