Toxic Alcohol Poisoning Clinical Trial
Official title:
Fomepizole Dosing During Continuous Renal Replacement Therapy (CRRT)
| NCT number | NCT04649138 |
| Other study ID # | 2017/981 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 13, 2019 |
| Est. completion date | December 2022 |
| Verified date | November 2020 |
| Source | Oslo University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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)
| Status | Recruiting |
| Enrollment | 10 |
| Est. completion date | December 2022 |
| Est. primary completion date | December 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Norway | Oslo University Hospital | Oslo |
| Lead Sponsor | Collaborator |
|---|---|
| Oslo University Hospital | Louisiana State University Health Sciences Center Shreveport |
Norway,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Continuous renal replacement therapy (CRRT) clearance of fomepizole | Plasma and dialysat samples will be obtained up to every hour | through study completion, up to 72 hours | |
| Secondary | Determine saturation/sieving coefficient of fomepizole | Plasma and dialysat samples will be obtained up to every hour | through study completion, up to 72 hours |