Augmented Renal ClearanceGFR-ARCNCT04776486
Iohexol Clearance in Critically Ill Patients With Augmented Renal Creatinine Clearance
A study testing Iohexol in people with Augmented Renal Clearance and Critically Ill, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Evaluation of glomerular filtration rate using iohexol plasma clearance in critically ill patients with augmented renal creatinine clearance Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Augmented Renal Clearance, Critically Ill
- 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
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 3 Sep 2020to 29 Jan 2026
- Phase
- Interventional
- 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
- ICU patient
- 24h Creatinine clearance >130ml/min/1.73m2
- Urinary catheterization
- Affiliation to a social security scheme
Who cannot join
- Pregnancy
- CT-scan with contrast media infusion the day of inclusion
- Documented allergy to contrast media
- Patient under guardianship / curatorship
- Patient benefiting from the "State Medical Assistance"
Trial locations and contacts
1 site in 1 country.
France1 site
Lariboisière Hospital, Surgical ICU
Paris, Île-de-France Region, 75010
About this study
Official title: Evaluation of Glomerular Filtration Rate Using Iohexol Plasma Clearance in Critically Ill Patients With Augmented Renal Creatinine Clearance
Evaluation of glomerular filtration rate using iohexol plasma clearance in critically ill patients with augmented renal creatinine clearance
Read the detailed description
Single center study in ICU patients with augmented renal clearance comparing glomerular filtration rate (GFR) as measured by iohexol plasma clearance to that measured by creatinine clearance. Primary objective is to compare the GFR estimates made by iohexol plasma clearance (as reference method) and creatinine clearance using Bland-Altman method.
Secondary objective are to compare GFR as measured by iohexol plasma clearance to that calculated with the most commonly used renal clearance estimating formulas (Cockcroft and Gault, MDRD and CKD-EPI ), evaluate clinical determinant of the observed differences and evaluate determinants of extracellular volume.
- Conditions
- Augmented Renal Clearance, Critically Ill
- Being tested
- Iohexol
- Keywords
- Iohexol, Augmented renal clearance, Intensive Care Unit
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IohexolDrug
Also called Omnipaque
Intravenous injection of 5 ml of iohexol (Omnipaque) to calculate the glomerular filtration rate (area under the curve).
Blood samples (2 ml) and urine (2 ml minimum) are to be collected for the determination of iohexol clearance at the following time points: pre-dose, 5 minutes, and 1, 2, 3, 4, 5, 6 hours post dose.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients with augmented renal clearance | Experimental | ICU patients with estimated renal clearance over 130ml/min/1.73m2 Receives: Drug: Iohexol |
What is being measured
The primary outcome is the main question the study is designed to answer.
GFR obtained by the iohexol clearance technique
GFR as measured by iohexol plasma clearance to evaluate its concordance, by the Bland and Altman method, with that obtained by measuring the clearance of creatinine.
Measured: 6 hours
GFR obtained by the creatinine clearance technique
GFR as measured by creatinine plasma clearance
Measured: 6 hours
Secondary outcomes (8)
GFR calculated using the Cockroft-Gault equation
Estimation of GFR using the Cockroft-Gault method based on the serum creatinine clearance measured on the day of intervention and the patient's weight of the day, and the agreement with the GFR measured by the iohexol clearance
Measured: 6 hours
GFR calculated using the Modification of diet in renal disease (MDRD) formula
Estimation of GFR using MDRD method based on the serum creatinine clearance measured on the day of intervention and the patient's weight of the day, and the agreement with the GFR measured by the iohexol clearance
Measured: 6 hours
GFR calculated using the Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) equation
Estimation of GFR using CKD-EPI method based on the serum creatinine clearance measured on the day of intervention and the patient's weight of the day, and the agreement with the GFR measured by the iohexol clearance
Measured: 6 hours
Plasmatic Levetiracetam dosing
To detect underdosing and risk of therapeutic failure of Levetiracetam
Measured: 6 hours
Plasmatic Vancomycin dosing
To detect underdosing and risk of therapeutic failure of Vancomycin
Measured: 6 hours
Plasmatic Piperacillin dosing
To detect underdosing and risk of therapeutic failure of Piperacillin
Measured: 6 hours
Plasmatic Cefotaxim dosing
To detect underdosing and risk of therapeutic failure of Cefotaxim
Measured: 6 hours
Plasmatic Aminoglycoside dosing
To detect underdosing and risk of therapeutic failure of Aminoglycoside
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start3 Sep 2020
- Primary completion29 Jan 2026
- Study completion29 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Augmented Renal ClearanceStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin G Chousterman, MD PhD, Principal investigator, Lariboisière Hospital, APHP Nord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776486
- Sponsor's protocol ID
- APHP190414
- Other IDs
- 2019-A00654-53
- Acronym
- GFR-ARC
- Status last verified
- Feb 2026
- First submitted
- 17 Jul 2020
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 27166722
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Glomerular Filtration Rate Using Iohexol Plasma Clearance in Critically Ill Patients With Augmented Renal Creatinine Clearance
- ClinicalTrials.gov ID
- NCT04776486
- Acronym / sponsor ID
- GFR-ARC / APHP190414
- Conditions
- Augmented Renal Clearance, Critically Ill
- Keywords
- Iohexol, Augmented renal clearance, Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 29 Jan 2026 (actual)
- Study completion
- 29 Jan 2026 (actual)
- First posted
- 1 Mar 2021 (actual)
- 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.
Evaluation of glomerular filtration rate using iohexol plasma clearance in critically ill patients with augmented renal creatinine clearance
Detailed description
Single center study in ICU patients with augmented renal clearance comparing glomerular filtration rate (GFR) as measured by iohexol plasma clearance to that measured by creatinine clearance. Primary objective is to compare the GFR estimates made by iohexol plasma clearance (as reference method) and creatinine clearance using Bland-Altman method.
Secondary objective are to compare GFR as measured by iohexol plasma clearance to that calculated with the most commonly used renal clearance estimating formulas (Cockcroft and Gault, MDRD and CKD-EPI ), evaluate clinical determinant of the observed differences and evaluate determinants of extracellular volume.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients with augmented renal clearance | Experimental | Drug: IohexolICU patients with estimated renal clearance over 130ml/min/1.73m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ICU patient
- 24h Creatinine clearance >130ml/min/1.73m2
- Urinary catheterization
- Affiliation to a social security scheme
Key exclusion criteria (5 listed)
- Pregnancy
- CT-scan with contrast media infusion the day of inclusion
- Documented allergy to contrast media
- Patient under guardianship / curatorship
- Patient benefiting from the "State Medical Assistance"
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 |
|---|---|---|
| IohexolAlso: OmnipaqueIntravenous injection of 5 ml of iohexol (Omnipaque) to calculate the glomerular filtration rate (area under the curve). Blood samples (2 ml) and urine (2 ml minimum) are to be collected for the determination of iohexol clearance at the following time points: pre-dose, 5 minutes, and 1, 2, 3, 4, 5, 6 hours post dose. | Drug | Critically ill patients with augmented renal clearance |
Primary outcome
GFR obtained by the iohexol clearance technique
Time frame: 6 hours
GFR as measured by iohexol plasma clearance to evaluate its concordance, by the Bland and Altman method, with that obtained by measuring the clearance of creatinine.
GFR obtained by the creatinine clearance technique
Time frame: 6 hours
GFR as measured by creatinine plasma clearance
8 secondary outcomes
GFR calculated using the Cockroft-Gault equation
Time frame: 6 hours
GFR calculated using the Modification of diet in renal disease (MDRD) formula
Time frame: 6 hours
GFR calculated using the Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) equation
Time frame: 6 hours
Plasmatic Levetiracetam dosing
Time frame: 6 hours
Plasmatic Vancomycin dosing
Time frame: 6 hours
Plasmatic Piperacillin dosing
Time frame: 6 hours
Plasmatic Cefotaxim dosing
Time frame: 6 hours
Plasmatic Aminoglycoside dosing
Time frame: 6 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 10 Feb 2026.
- Background: 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.
- Individual participant dataSharing planned: Undecided
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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.
Benjamin G Chousterman, MD PhD principal investigator
Lariboisière Hospital, APHP Nord
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iohexol in people with Augmented Renal Clearance and Critically Ill, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 4 inclusion and 5 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 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
GFR obtained by the iohexol clearance technique (time frame: 6 hours). The study lists 2 primary outcomes in all. 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 NCT04776486, which also lists 1 linked publication.
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 10 Feb 2026.