Fomepizole Dosing During Continuous Renal Replacement Therapy (CRRT)

April 1, 2025 updated by: Knut Erik Hovda, MD, PhD, Oslo University Hospital
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)

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Toxic alcohol poisoning treated with fomepizole and CRRT.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, up to 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, up to 72 hours
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
through study completion, up to 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Louisiana State University Health Sciences Center Shreveport

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2019

Primary Completion (Actual)

November 26, 2020

Study Completion (Actual)

November 26, 2020

Study Registration Dates

First Submitted

October 30, 2020

First Submitted That Met QC Criteria

November 24, 2020

First Posted (Actual)

December 2, 2020

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/981

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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