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Fomepizole Dosing During Continuous Renal Replacement Therapy (CRRT)

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ClinicalTrials.gov Identifier: NCT04649138
Recruitment Status : Recruiting
First Posted : December 2, 2020
Last Update Posted : December 2, 2020
Sponsor:
Collaborator:
Louisiana State University Health Sciences Center Shreveport
Information provided by (Responsible Party):
Knut Erik Hovda, Oslo University Hospital

Study Description
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Brief Summary:
The project is a prospective observation study of patients with suspected or confirmed toxic alcohol poisoning treated with fomepizole and continuous renal replacement therapy (CRRT)

Condition or disease
Toxic Alcohol Poisoning

Study Design
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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Fomepizole Dosing During Continuous Renal Replacement Therapy (CRRT)
Actual Study Start Date : June 13, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Measure minimum plasma concentration of fomepizole [ Time Frame: through study completion, up to 72 hours ]
    Plasma samples will be obtained up to every hour and before fomepizole is given


Secondary Outcome Measures :
  1. Continuous renal replacement therapy (CRRT) clearance of fomepizole [ Time Frame: through study completion, up to 72 hours ]
    Plasma and dialysat samples will be obtained up to every hour

  2. Determine saturation/sieving coefficient of fomepizole [ Time Frame: through study completion, up to 72 hours ]
    Plasma and dialysat samples will be obtained up to every hour


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
Sampling Method:   Non-Probability Sample
Study Population
Toxic alcohol poisoning treated with fomepizole and CRRT.
Criteria

Inclusion Criteria:

  • Patients (over 18 year) with suspected or confirmed toxic alcohol poisoning treated with fomepizole and CRRT.

Exclusion Criteria:

  • Patients who wish to withdraw from the study
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): NCT04649138


Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Knut Erik Hovda, MD,PhD    +47 99618356    UXKNOV@ous-hf.no   
Contact: Yvonne Lao, M.Sc.       yvonnela@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
Louisiana State University Health Sciences Center Shreveport
More Information
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Responsible Party: Knut Erik Hovda, Principal Investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04649138    
Other Study ID Numbers: 2017/981
First Posted: December 2, 2020    Key Record Dates
Last Update Posted: December 2, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Poisoning
Chemically-Induced Disorders