Actively Recruiting
The Efficacy of Dexamethasone Combined With N-acetylcysteine in Preventing Neurocognitive Sequelae After Carbon Monoxide Poisoning
Led by China Medical University Hospital · Updated on 2025-03-26
128
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Carbon monoxide (CO) poisoning is a serious health problem that can lead to delayed neuropsychological sequelae (DNS), which involve damage due to oxidative stress, inflammation, and immune system injury. While hyperbaric oxygen therapy is commonly used, its ability to prevent DNS is uncertain. Researchers are studying whether combining Dexamethasone, an anti-inflammatory drug, with N-acetylcysteine, an antioxidant, can better prevent these delayed effects after CO poisoning. The study evaluates two groups: one receiving a combination treatment of Dexamethasone and N-acetylcysteine, and a control group receiving a placebo. The Dexamethasone is given as a 10mg intravenous dose immediately and once daily for three days, while N-acetylcysteine is administered intravenously at 200 mg/kg over 4 hours, followed by 100 mg/kg over 16 hours. This randomized, triple-masked trial aims to compare the incidence of DNS between the treated and control groups. Participants will be monitored for the development of delayed neurological sequelae at 2 weeks, 6 weeks, and 3 months through clinical evaluations. Cognitive function will also be assessed using the Mini-Mental State Examination at these time points. The study will track safety and outcomes to determine if the combination treatment reduces the risk of cognitive and neurological problems after CO poisoning, with a total follow-up of at least three months.
CONDITIONS
Brief Title
The Efficacy of Dexamethasone in Combination With N-acetylcysteine in Preventing Neurocognitive Sequelae Due to Carbon Monoxide Poisoning
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History and clinical symptoms consistent with carbon monoxide poisoning
- Initial blood carboxyhemoglobin (COHb) levels greater than 5%, or greater than 10% for smokers
- Age 18 years or older
- Ability and willingness to sign the consent form
You will not qualify if you...
- Concurrent use of other potentially lethal toxins
- Severe trauma or burns that could be fatal
- No spontaneous heartbeat or blood pressure before hospital arrival
- Poisoning time exceeding 24 hours before hospital arrival
- Minors under 18 years of age
- Pregnant women
- Refusal to sign consent form by patient or family
- Contraindications for Dexamethasone or N-acetylcysteine such as severe allergies or when risks outweigh benefits assessed by physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants receive dexamethasone and N-acetylcysteine or placebo to prevent neurocognitive effects after carbon monoxide poisoning.
1 treatment period with intravenous medication administration
Duration - 3 months
Participants are monitored for delayed neurological and cognitive effects after treatment.
Visits at 2 weeks, 6 weeks, and 3 months for clinical evaluation and cognitive assessment
Trial Site Locations
Total: 1 location
1
China Medical University Hospital
Taichung, Taiwan, 404022
Actively Recruiting
Research Team
C
Chi-Syuan Pan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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