NCT04776486

Brief Summary

Evaluation of glomerular filtration rate using iohexol plasma clearance in critically ill patients with augmented renal creatinine clearance

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 3, 2020

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2026

Completed
Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

5.4 years

First QC Date

July 17, 2020

Last Update Submit

February 8, 2026

Conditions

Augmented Renal ClearanceCritically Ill

Keywords

IohexolAugmented renal clearanceIntensive Care Unit

Outcome Measures

Primary Outcomes (2)

  • 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.

    6 hours

  • GFR obtained by the creatinine clearance technique

    GFR as measured by creatinine plasma clearance

    6 hours

Secondary Outcomes (8)

  • GFR calculated using the Cockroft-Gault equation

    6 hours

  • GFR calculated using the Modification of diet in renal disease (MDRD) formula

    6 hours

  • GFR calculated using the Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) equation

    6 hours

  • Plasmatic Levetiracetam dosing

    6 hours

  • Plasmatic Vancomycin dosing

    6 hours

  • +3 more secondary outcomes

Study Arms (1)

Critically ill patients with augmented renal clearance

EXPERIMENTAL

ICU patients with estimated renal clearance over 130ml/min/1.73m2

Drug: Iohexol

Interventions

IohexolDRUG

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.

Also known as: Omnipaque
Critically ill patients with augmented renal clearance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ICU patient
  • h Creatinine clearance \>130ml/min/1.73m2
  • Urinary catheterization
  • Affiliation to a social security scheme

You may not qualify if:

  • Pregnancy
  • Documented allergy to contrast media
  • Patient under guardianship / curatorship
  • Patient benefiting from the "State Medical Assistance"

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lariboisière Hospital, Surgical ICU

Paris, Île-de-France Region, 75010, France

Location

Related Publications (1)

  • 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.

    PMID: 27166722BACKGROUND

MeSH Terms

Conditions

Critical Illness

Interventions

Iohexol

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triiodobenzoic AcidsIodobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Benjamin G Chousterman, MD PhD

    Lariboisière Hospital, APHP Nord

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2020

First Posted

March 1, 2021

Study Start

September 3, 2020

Primary Completion

January 29, 2026

Study Completion

January 29, 2026

Last Updated

February 10, 2026

Record last verified: 2026-02

Locations

FR(1)