NCT06549621

Brief Summary

Carbon monoxide poisoning is a frequent domestic accident and the leading cause of death from unintentionnal poisoning. Its toxicity is based on the CO binding to hemoglobin and myoglobin, inhibition of mitochondrial cytochrome oxidase, resulting in tissue hypoxia and reduced adenosine triphosphate synthesis and ischemia-reperfusion injury. This study aims to investigate the early and late cardiologic effects of CO in patients treated with hyperbaric oxygen (HBOT) for CO poisoning

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2022

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2024

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

August 8, 2024

Last Update Submit

August 8, 2024

Conditions

Keywords

cardiac injurycardiac toxicity

Outcome Measures

Primary Outcomes (1)

  • early and late cardiac injury due to CO poisoning description

    clinical manifestation, troponin elevation and/or ECG abnormality during acute CO poisoning description; then late cardiac manifestation and abnormality declared by patients who have had early cardiac abnormality (troponin elevation and/or ECG abnormalities)

    enrollment (inclusion)

Secondary Outcomes (5)

  • relationship between the source of CO poisoning and cardiac injury

    enrollment (inclusion)

  • relationship between context of poisoning (domestic, professionnal or intentional poisoning) and cardiac injury

    enrollment (inclusion)

  • relationship between other possibly associated poisoning and cardiac injury

    enrollment (inclusion)

  • relationship between severity of neurological symptoms and cardiac injury

    enrollment (inclusion)

  • relationship between cardiovascular risk factors or preexisting cardio vascular abnormality and cardiac injury

    enrollment (inclusion)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients treated for CO poisoning with HBOT following European and French recommendations in our department from 2015/01/01 to 2021/12/31

You may qualify if:

  • Patients treated for CO poisoning with HBOT in the hyperbaric and underwater medicine department of the Brest University hospital from 2015/01/01 to 2021/12/31

You may not qualify if:

  • refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29909, France

RECRUITING

MeSH Terms

Conditions

Carbon Monoxide PoisoningCardiotoxicity

Condition Hierarchy (Ancestors)

Gas PoisoningPoisoningChemically-Induced DisordersHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsRadiation InjuriesWounds and Injuries

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2024

First Posted

August 12, 2024

Study Start

July 25, 2022

Primary Completion

October 25, 2022

Study Completion

October 25, 2024

Last Updated

August 12, 2024

Record last verified: 2024-08

Locations