NCT04229732

Brief Summary

This prospective, randomized control trial will use passive, isocapnic hyperventilation, applied via the ClearMateTM device (Thornhill Medical, Inc) versus controls receiving standard of care supportive management for severe alcohol intoxication to assess for enhanced ethanol elimination kinetics.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

January 13, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

January 13, 2020

Last Update Submit

January 13, 2020

Conditions

Alcohol Intoxication

Outcome Measures

Primary Outcomes (1)

  • Alcohol elimination time constant

    From the recorded venous ethanol blood alcohol values, an elimination time constant will be calculated

    6-24 hours

Study Arms (2)

ClearMate Intervention

EXPERIMENTAL

Participants undergo passive isocapnic hyperventilation via the ClearMateTM device and have regular venous blood samples obtained to measure ethanol clearance kinetics.

Device: ClearMateTM

Supportive Management

NO INTERVENTION

Participants receive standard of care, supportive management, for alcohol intoxication, having regular venous blood samples obtained to measure ethanol clearance kinetics.

Interventions

ClearMateTMDEVICE

Passive isocapnic hyperventilation breathing circuit.

ClearMate Intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsGenders will be noted and used for separate analysis due to known gender differences in alcohol elimination kinetics.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • intoxicated requiring admission to an emergency unit

You may not qualify if:

  • Liver or renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alcoholic Intoxication

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2020

First Posted

January 18, 2020

Study Start

July 1, 2020

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

January 18, 2020

Record last verified: 2020-01