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

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ClinicalTrials.gov Identifier: NCT04776486
Recruitment Status : Recruiting
First Posted : March 1, 2021
Last Update Posted : March 23, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:
Evaluation of glomerular filtration rate using iohexol plasma clearance in critically ill patients with augmented renal creatinine clearance

Condition or disease Intervention/treatment Phase
Augmented Renal Clearance Critically Ill Drug: Iohexol Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Glomerular Filtration Rate Using Iohexol Plasma Clearance in Critically Ill Patients With Augmented Renal Creatinine Clearance
Actual Study Start Date : September 3, 2020
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Iohexol

Arms and Interventions
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Arm Intervention/treatment
Experimental: Critically ill patients with augmented renal clearance
ICU patients with estimated renal clearance over 130ml/min/1.73m2
 Drug: 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.

Other Name: Omnipaque


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. GFR obtained by the creatinine clearance technique [ Time Frame: 6 hours ]
    GFR as measured by creatinine plasma clearance


Secondary Outcome Measures :
  1. GFR calculated using the Cockroft-Gault equation [ Time Frame: 6 hours ]
    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

  2. GFR calculated using the Modification of diet in renal disease (MDRD) formula [ Time Frame: 6 hours ]
    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

  3. GFR calculated using the Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) equation [ Time Frame: 6 hours ]
    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

  4. Plasmatic Levetiracetam dosing [ Time Frame: 6 hours ]
    To detect underdosing and risk of therapeutic failure of Levetiracetam

  5. Plasmatic Vancomycin dosing [ Time Frame: 6 hours ]
    To detect underdosing and risk of therapeutic failure of Vancomycin

  6. Plasmatic Piperacillin dosing [ Time Frame: 6 hours ]
    To detect underdosing and risk of therapeutic failure of Piperacillin

  7. Plasmatic Cefotaxim dosing [ Time Frame: 6 hours ]
    To detect underdosing and risk of therapeutic failure of Cefotaxim

  8. Plasmatic Aminoglycoside dosing [ Time Frame: 6 hours ]
    To detect underdosing and risk of therapeutic failure of Aminoglycoside


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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"
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04776486


Contacts
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Contact: Magalie Collet, MD +33 (0)149958515 magalie.collet@aphp.fr

Locations
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France
Lariboisière Hospital, Surgical ICU Recruiting
Paris, Ile De France, France, 75010
Contact: Magalie Collet, MD    +33 (0)149958515    magalie.collet@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Benjamin G Chousterman, MD PhD Lariboisière Hospital, APHP Nord
More Information
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Publications:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04776486    
Other Study ID Numbers: APHP190414
2019-A00654-53 ( Other Identifier: IDRCB )
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Iohexol
Augmented renal clearance
Intensive Care Unit
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes