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

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Recruiting
CT.gov ID
NCT04776486
Collaborator
(none)
90
Enrollment
1
Location
1
Arm
35.9
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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
N/A

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

Study Type:
Interventional
Anticipated 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 :
Sep 3, 2020
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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 Names:
  • Omnipaque

    		•

    Outcome Measures

    Primary Outcome Measures

    1. GFR obtained by the iohexol clearance technique [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 [6 hours]

      GFR as measured by creatinine plasma clearance

    Secondary Outcome Measures

    1. GFR calculated using the Cockroft-Gault equation [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 [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 [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 [6 hours]

      To detect underdosing and risk of therapeutic failure of Levetiracetam

    5. Plasmatic Vancomycin dosing [6 hours]

      To detect underdosing and risk of therapeutic failure of Vancomycin

    6. Plasmatic Piperacillin dosing [6 hours]

      To detect underdosing and risk of therapeutic failure of Piperacillin

    7. Plasmatic Cefotaxim dosing [6 hours]

      To detect underdosing and risk of therapeutic failure of Cefotaxim

    8. Plasmatic Aminoglycoside dosing [6 hours]

      To detect underdosing and risk of therapeutic failure of Aminoglycoside

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Lariboisière Hospital, Surgical ICU Paris Ile De France France 75010

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    • Principal Investigator: Benjamin G Chousterman, MD PhD, Lariboisière Hospital, APHP Nord

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

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

    Study Results

    No Results Posted as of Mar 23, 2021