NCT04925297

Brief Summary

The purpose of this study is to access the clinical characteristics and risk factors for neurological sequelae after acute carbon monoxide poisoning.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
1,250

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Aug 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress83%
Aug 2021May 2027

First Submitted

Initial submission to the registry

May 26, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 14, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

June 14, 2021

Status Verified

May 1, 2021

Enrollment Period

5.8 years

First QC Date

May 26, 2021

Last Update Submit

June 7, 2021

Conditions

Carbon Monoxide Poisoning

Keywords

carbon monoxide poisoningneurological sequelae

Outcome Measures

Primary Outcomes (20)

  • Changes of Mini-mental State Examination (MMSE) score at 6 weeks

    Score ranges from 0 to 30, a lower score means a worse outcome.

    Changes of score from baseline to 6 weeks

  • Changes of Mini-mental State Examination (MMSE) score at 6 months

    Score ranges from 0 to 30, a lower score means a worse outcome.

    Changes of score from baseline to 6 months

  • Changes of Mini-mental State Examination (MMSE) score at 12 months

    Score ranges from 0 to 30, a lower score means a worse outcome.

    Changes of score from baseline to 12 months

  • Changes of Montreal cognitive assessment (MoCA）score at 6 weeks

    Score ranges from 0 to 30, a lower score means a worse outcome.

    Changes of score from baseline to 6 weeks

  • Changes of Montreal cognitive assessment (MoCA）score at 6 months

    Score ranges from 0 to 30, a lower score means a worse outcome.

    Changes of score from baseline to 6 months

  • Changes of Montreal cognitive assessment (MoCA）score at 12 months

    Score ranges from 0 to 30, a lower score means a worse outcome.

    Changes of score from baseline to 12 months

  • Changes of Hamilton Depression Scale(HAMD) score at 6 weeks

    Score ranges from 0 to 54, a higher score means a worse outcome.

    Changes of score from baseline to 6 weeks

  • Changes of Hamilton Depression Scale(HAMD) score at 6 months

    Score ranges from 0 to 54, a higher score means a worse outcome.

    Changes of score from baseline to 6 months

  • Changes of Hamilton Depression Scale(HAMD) score at 12 months

    Score ranges from 0 to 54, a higher score means a worse outcome.

    Changes of score from baseline to 12 months

  • Changes of Hamilton Anxiety Scale (HAMA) score at 6 weeks

    Score ranges from 0 to 56, a higher score means a worse outcome.

    Changes of score from baseline to 6 weeks

  • Changes of Hamilton Anxiety Scale (HAMA) score at 6 months

    Score ranges from 0 to 56, a higher score means a worse outcome.

    Changes of score from baseline to 6 months

  • Changes of Hamilton Anxiety Scale (HAMA) score at 12 months

    Score ranges from 0 to 56, a higher score means a worse outcome.

    Changes of score from baseline to 12 months

  • Changes of Activity of Daily Living (ADL) score at 6 weeks

    Score ranges from 0 to 80, a higher score means a worse outcome.

    Changes of score from baseline to 6 weeks

  • Changes of Activity of Daily Living (ADL) score at 6 months

    Score ranges from 0 to 80, a higher score means a worse outcome.

    Changes of score from baseline to 6 months

  • Changes of Activity of Daily Living (ADL) score at 12 months

    Score ranges from 0 to 80, a higher score means a worse outcome.

    Changes of score from baseline to 12 months

  • Changes of self-evaluation of discomfort symptoms scale at 1 week

    This is a self designed questionnaire, score ranges from 0 to 66, a higher score means a worse outcome

    Changes of score from baseline to 1 week

  • Changes of self-evaluation of discomfort symptoms scale at 3 weeks

    This is a self designed questionnaire, score ranges from 0 to 66, a higher score means a worse outcome

    Changes of score from baseline to 3 weeks

  • Changes of self-evaluation of discomfort symptoms scale at 6 weeks

    This is a self designed questionnaire, score ranges from 0 to 66, a higher score means a worse outcome

    Changes of score from baseline to 6 weeks

  • Changes of self-evaluation of discomfort symptoms scale at 6 months

    This is a self designed questionnaire, score ranges from 0 to 66, a higher score means a worse outcome

    Changes of score from baseline to 6 months

  • Changes of self-evaluation of discomfort symptoms scale at 12 months

    This is a self designed questionnaire, score ranges from 0 to 66, a higher score means a worse outcome

    Changes of score from baseline to 12 months

Secondary Outcomes (2)

  • Rates of cardiovascular and cerebrovascular events

    through study completion, an average of 1 year

  • Rates of accidental injury

    through study completion, an average of 1 year

Study Arms (2)

Non-NS ( Non-neurological sequelae) group

Patients who do not develop neurological dysfunction after acute carbon monoxide poisoning

Other: No intervention

NS (Neurological sequelae) group

Patients who develop neurological dysfunction after acute carbon monoxide poisoning

Other: No intervention

Interventions

No interventionOTHER

No intervention will be given

NS (Neurological sequelae) groupNon-NS ( Non-neurological sequelae) group

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All the patients with acute carbon monoxide poisoning would be recruited from the First Hospital of Jilin University.

You may qualify if:

  • patients present within 12 hours after acute carbon monoxide poisoning;
  • age older than 16 years.

You may not qualify if:

  • pregnant women；
  • patients receive oxygen therapy before presentation;
  • have history of acute carbon monoxide poisoning within 1 year;
  • have been diagnosed any of the following disease: Parkinson disease; cognitive disorder, psychiatric disorders, sequelae of cerebral infarction or hemorrhage, chronic kidney disease and receive hemodialysis, congestive heart failure ( NYHA class III-IV)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood serum

MeSH Terms

Conditions

Carbon Monoxide Poisoning

Condition Hierarchy (Ancestors)

Gas PoisoningPoisoningChemically-Induced Disorders

Study Officials

  • Li Pang, M.D.

    The First Hospital of Jilin University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ning Dong, M.D.

CONTACT

+8615804301769dnjl2007@jlu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2021

First Posted

June 14, 2021

Study Start

August 1, 2021

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

June 14, 2021

Record last verified: 2021-05

Locations

CN(1)