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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04925297
Other study ID # AF-IRB-030-06
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 1, 2021
Est. completion date May 1, 2027

Study information

Verified date May 2021
Source The First Hospital of Jilin University
Contact Ning Dong, M.D.
Phone +8615804301769
Email dnjl2007@jlu.edu.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


Description:

After being informed about the study and potential risks, patients meet the inclusion criteria would be given informed consent and entry the study. The data will be collected according to self-designed questionnaire, including :1) The baseline characteristics: would be recorded 6 hours after patients presentation;2) Patients' self evaluation for discomfort symptoms: would be recorded at day 0, week 1, 3 and 6, month 6 and 12;3) Neurological function: would be recorded at day 0, week 6, month 6 and 12.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1250
Est. completion date May 1, 2027
Est. primary completion date May 1, 2027
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - patients present within 12 hours after acute carbon monoxide poisoning; - age older than 16 years. Exclusion Criteria: - 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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
No intervention will be given

Locations

Country Name City State
China First Hospital of Jilin University Chang chun Jilin

Sponsors (1)

Lead Sponsor Collaborator
The First Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Rates of cardiovascular and cerebrovascular events Cardiovascular and cerebrovascular events includes:cardiac arrest, myocardial infarction, cerebral hemorrhage, and cerebral infarction. A patient develops any of the former diseases during following up would be record as 1 event. through study completion, an average of 1 year
Secondary Rates of accidental injury Accidental injuries may include accidental fall, fracture, traffic accident etc. A patient develops any of the former during following up would be record as 1 event. through study completion, an average of 1 year
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