Toxic Alcohol PoisoningNCT04649138
Fomepizole Dosing During Continuous Renal Replacement Therapy (CRRT)
An observational study of Toxic Alcohol Poisoning, run by Oslo University Hospital at 1 site in Norway.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Toxic Alcohol Poisoning
- How many people
- 11 participants
- Where
- 1 siteNorway
- Study dates
- 13 Jun 2019to 26 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Toxic alcohol poisoning treated with fomepizole and CRRT.
Who may be able to join
- Patients (over 18 year) with suspected or confirmed toxic alcohol poisoning treated with fomepizole and CRRT.
Who cannot join
- Patients who wish to withdraw from the study
Trial locations and contacts
1 site in 1 country.
About this study
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)
- Conditions
- Toxic Alcohol Poisoning
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure minimum plasma concentration of fomepizole
Plasma samples will be obtained up to every hour and before fomepizole is given
Measured: through study completion, up to 72 hours
Secondary outcomes (2)
Continuous renal replacement therapy (CRRT) clearance of fomepizole
Plasma and dialysat samples will be obtained up to every hour
Measured: through study completion, up to 72 hours
Determine saturation/sieving coefficient of fomepizole
Plasma and dialysat samples will be obtained up to every hour
Measured: through study completion, up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start13 Jun 2019
- Primary completion26 Nov 2020
- Study completion26 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Toxic Alcohol PoisoningStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Louisiana State University Health Sciences Center Shreveport
- Responsible party
- Principal investigator, Knut Erik Hovda, MD, PhD, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649138
- Sponsor's protocol ID
- 2017/981
- Status last verified
- Nov 2020
- First submitted
- 30 Oct 2020
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fomepizole Dosing During Continuous Renal Replacement Therapy (CRRT)
- ClinicalTrials.gov ID
- NCT04649138
- Acronym / sponsor ID
- 2017/981
- Conditions
- Toxic Alcohol Poisoning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Louisiana State University Health Sciences Center Shreveport
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 26 Nov 2020 (actual)
- Study completion
- 26 Nov 2020 (actual)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Toxic alcohol poisoning treated with fomepizole and CRRT.
Key inclusion criteria (1 listed)
- Patients (over 18 year) with suspected or confirmed toxic alcohol poisoning treated with fomepizole and CRRT.
Key exclusion criteria (1 listed)
- Patients who wish to withdraw from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Continuous renal replacement therapy (CRRT) clearance of fomepizole
Time frame: through study completion, up to 72 hours
Determine saturation/sieving coefficient of fomepizole
Time frame: through study completion, up to 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Toxic Alcohol Poisoning, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure minimum plasma concentration of fomepizole (time frame: through study completion, up to 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025; AzTrials last refreshed its copy on 1 Nov 2026.