NCT04649138

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2020

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 2, 2020

Completed
Last Updated

April 4, 2025

Status Verified

November 1, 2020

Enrollment Period

1.5 years

First QC Date

October 30, 2020

Last Update Submit

April 1, 2025

Conditions

Toxic Alcohol Poisoning

Outcome Measures

Primary Outcomes (1)

  • Measure minimum plasma concentration of fomepizole

    Plasma samples will be obtained up to every hour and before fomepizole is given

    through study completion, up to 72 hours

Secondary Outcomes (2)

  • Continuous renal replacement therapy (CRRT) clearance of fomepizole

    through study completion, up to 72 hours

  • Determine saturation/sieving coefficient of fomepizole

    through study completion, up to 72 hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Toxic alcohol poisoning treated with fomepizole and CRRT.

You may qualify if:

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

You may not qualify if:

  • Patients who wish to withdraw from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 30, 2020

First Posted

December 2, 2020

Study Start

June 13, 2019

Primary Completion

November 26, 2020

Study Completion

November 26, 2020

Last Updated

April 4, 2025

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)