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Iohexol Clearance in Critically Ill Patients With Augmented Renal Creatinine Clearance (GFR-ARC)

Primary Purpose

Augmented Renal Clearance, Critically Ill

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Iohexol
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Augmented Renal Clearance focused on measuring Iohexol, Augmented renal clearance, Intensive Care Unit

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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"

Sites / Locations

  • Lariboisière Hospital, Surgical ICURecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Critically ill patients with augmented renal clearance

Arm Description

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

Outcomes

Primary Outcome Measures

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.
GFR obtained by the creatinine clearance technique
GFR as measured by creatinine plasma clearance

Secondary Outcome Measures

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
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
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
Plasmatic Levetiracetam dosing
To detect underdosing and risk of therapeutic failure of Levetiracetam
Plasmatic Vancomycin dosing
To detect underdosing and risk of therapeutic failure of Vancomycin
Plasmatic Piperacillin dosing
To detect underdosing and risk of therapeutic failure of Piperacillin
Plasmatic Cefotaxim dosing
To detect underdosing and risk of therapeutic failure of Cefotaxim
Plasmatic Aminoglycoside dosing
To detect underdosing and risk of therapeutic failure of Aminoglycoside

Full Information

First Posted
July 17, 2020
Last Updated
March 19, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04776486
Brief Title
Iohexol Clearance in Critically Ill Patients With Augmented Renal Creatinine Clearance
Acronym
GFR-ARC
Official Title
Evaluation of Glomerular Filtration Rate Using Iohexol Plasma Clearance in Critically Ill Patients With Augmented Renal Creatinine Clearance
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 3, 2020 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Augmented Renal Clearance, Critically Ill
Keywords
Iohexol, Augmented renal clearance, Intensive Care Unit

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Critically ill patients with augmented renal clearance
Arm Type
Experimental
Arm Description
ICU patients with estimated renal clearance over 130ml/min/1.73m2
Intervention Type
Drug
Intervention Name(s)
Iohexol
Other Intervention Name(s)
Omnipaque
Intervention Description
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.
Primary Outcome Measure Information:
Title
GFR obtained by the iohexol clearance technique
Description
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.
Time Frame
6 hours
Title
GFR obtained by the creatinine clearance technique
Description
GFR as measured by creatinine plasma clearance
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
GFR calculated using the Cockroft-Gault equation
Description
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
Time Frame
6 hours
Title
GFR calculated using the Modification of diet in renal disease (MDRD) formula
Description
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
Time Frame
6 hours
Title
GFR calculated using the Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) equation
Description
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
Time Frame
6 hours
Title
Plasmatic Levetiracetam dosing
Description
To detect underdosing and risk of therapeutic failure of Levetiracetam
Time Frame
6 hours
Title
Plasmatic Vancomycin dosing
Description
To detect underdosing and risk of therapeutic failure of Vancomycin
Time Frame
6 hours
Title
Plasmatic Piperacillin dosing
Description
To detect underdosing and risk of therapeutic failure of Piperacillin
Time Frame
6 hours
Title
Plasmatic Cefotaxim dosing
Description
To detect underdosing and risk of therapeutic failure of Cefotaxim
Time Frame
6 hours
Title
Plasmatic Aminoglycoside dosing
Description
To detect underdosing and risk of therapeutic failure of Aminoglycoside
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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"
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magalie Collet, MD
Phone
+33 (0)149958515
Email
magalie.collet@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin G Chousterman, MD PhD
Organizational Affiliation
Lariboisière Hospital, APHP Nord
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lariboisière Hospital, Surgical ICU
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magalie Collet, MD
Phone
+33 (0)149958515
Email
magalie.collet@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27166722
Citation
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.
Results Reference
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Iohexol Clearance in Critically Ill Patients With Augmented Renal Creatinine Clearance

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