Iohexol Clearance in Critically Ill Patients With Augmented Renal Creatinine Clearance

NCT ID: NCT04776486

Last Updated: 2024-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-03

Study Completion Date

2024-03-31

Brief Summary

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

Detailed Description

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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

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Augmented Renal Clearance Critically Ill

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Critically ill patients with augmented renal clearance

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

Group Type EXPERIMENTAL

Iohexol

Intervention Type DRUG

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.

Interventions

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Iohexol

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.

Intervention Type DRUG

Other Intervention Names

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Omnipaque

Eligibility Criteria

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Inclusion Criteria

* ICU patient
* 24h Creatinine clearance \>130ml/min/1.73m2
* Urinary catheterization
* Affiliation to a social security scheme

Exclusion Criteria

* 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"
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benjamin G Chousterman, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Lariboisière Hospital, APHP Nord

Locations

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Lariboisière Hospital, Surgical ICU

Paris, Île-de-France Region, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Magalie Collet, MD

Role: CONTACT

+33 (0)149958515

Facility Contacts

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Magalie Collet, MD

Role: primary

+33 (0)149958515

References

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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.

Reference Type BACKGROUND
PMID: 27166722 (View on PubMed)

Other Identifiers

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2019-A00654-53

Identifier Type: OTHER

Identifier Source: secondary_id

APHP190414

Identifier Type: -

Identifier Source: org_study_id

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