Carbon Monoxide PoisoningPhase 4NCT06811675
The Efficacy of Dexamethasone in Combination With N-acetylcysteine in Preventing Neurocognitive Sequelae Due to Carbon Monoxide Poisoning
A Phase 4 study testing Dexamethasone and N-acetylcysteine (NAC) in people with Carbon Monoxide Poisoning and Delayed Neurocognitive Sequelae, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Background and Aim: Carbon monoxide (CO) poisoning is a significant public health issue that can cause delayed neuropsychological sequelae (DNS). DNS mechanisms involve oxidative stress, inflammation, and immune injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carbon Monoxide Poisoning, Delayed Neurocognitive Sequelae
- What is being tested?
- Dexamethasone and N-acetylcysteine (NAC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Mar 2025to 30 Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History and clinical symptoms consistent with CO poisoning (initial blood carboxyhemoglobin (COHb) levels >5%, or >10% for smokers).
Who cannot join
- Concurrent use of other potentially lethal toxins. Severe trauma or burns that could be fatal. No spontaneous heartbeat or blood pressure before arrival. Poisoning time exceeding 24 hours before hospital arrival. Minors (under 18 years of age). Pregnant women. Patients or their families refuse to sign the consent form. Contraindications for the use of Dexamethasone or N-acetylcysteine (such as severe allergies) or when the physician assesses the risks outweigh the benefits.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, 404022
Chi-Syuan Pan, 0912697916, miss321@gmail.com
About this study
Background and Aim: Carbon monoxide (CO) poisoning is a significant public health issue that can cause delayed neuropsychological sequelae (DNS). DNS mechanisms involve oxidative stress, inflammation, and immune injury. Although hyperbaric oxygen therapy is widely used, its efficacy in preventing DNS remains inconclusive. Preclinical and retrospective studies suggest that Dexamethasone (anti-inflammatory and immunosuppressive) and N-acetylcysteine (antioxidant) may reduce DNS risk. This study hypothesizes that their combination can effectively prevent DNS.
Methods: This prospective pre-post intervention study will enroll CO poisoning patients into treatment (Dexamethasone + N-acetylcysteine) and control groups. The primary outcome is the incidence of DNS within six weeks post-treatment.
Objective: To determine whether combining Dexamethasone and N-acetylcysteine reduces the incidence of DNS following CO poisoning.
- Being tested
- Dexamethasone and N-acetylcysteine (NAC), Placebo
- Keywords
- Carbon Monoxide Poisoning, Dexamethasone, N-acetylcysteine, Delayed Neurocognitive Sequelae
- Medical subject headings
- Carbon Monoxide Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone and N-acetylcysteine (NAC)Drug
Dexamethasone 10mg IV STAT +QD for 3 days+NAC IV 200mg/kg over 4 hours, then 100 mg/kg over 16 hours
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| dexamethasone and n-acetylcysteine | Experimental | Dexamethasone 10mg IV STAT +QD for 3 days+NAC IV 200mg/kg over 4 h, then 100 mg/kg over 16 h Receives: Drug: Dexamethasone and N-acetylcysteine (NAC) |
| placebo | Placebo comparator | normal saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with delayed neurological sequelae following carbon monoxide exposure, as assessed by clinical evaluation
Questionnaire:
Parkinson-like syndromes Concentration deficits Gait and motor disturbances Memory loss Bradykinesia Cognitive impairment Intention tremor Dementia Myoclonus Personality changes Dyspraxia Anxiety Dysphasia Extreme emotional lability Ataxia Psychosis Postural instability Depression Vertigo Mania Cortical blindness Insomnia Hearing loss, tinnitus Chorea EEG abnormalities Epilepsy Peripheral neuropathies Recurrent headaches Fecal or urinary incontinence
Criteria:
The presence of any delayed-onset symptoms listed above, emerging at least 2 days after initial recovery from carbon monoxide poisoning, will require confirmation by a toxicologist, neurologist, or psychiatrist experienced in diagnosing delayed neuropsychiatric sequelae (DNS) following CO exposure.
Measured: 2 weeks, 6 weeks, 3 months
Secondary outcomes (1)
Number of participants with cognitive impairment following carbon monoxide exposure, as assessed by the Mini-Mental State Examination (MMSE)
Cognitive impairment will be assessed using the Mini-Mental State Examination (MMSE) at 2 weeks, 6 weeks, and 3 months post-exposure. A score of ≥24 (out of 30) indicates normal cognition, while lower scores indicate varying degrees of impairment: mild (19-23), moderate (10-18), and severe (≤9). The number of participants meeting the criteria for cognitive impairment will be recorded at each time point.
Measured: 2 weeks, 6 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start23 Mar 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbon Monoxide PoisoningStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811675
- Sponsor's protocol ID
- CMUH113-REC1-201
- Status last verified
- Mar 2025
- First submitted
- 3 Feb 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Dexamethasone in Combination With N-acetylcysteine in Preventing Neurocognitive Sequelae Due to Carbon Monoxide Poisoning
- ClinicalTrials.gov ID
- NCT06811675
- Acronym / sponsor ID
- CMUH113-REC1-201
- Keywords
- Carbon Monoxide Poisoning, Dexamethasone, N-acetylcysteine, Delayed Neurocognitive Sequelae
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 23 Mar 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background and Aim: Carbon monoxide (CO) poisoning is a significant public health issue that can cause delayed neuropsychological sequelae (DNS). DNS mechanisms involve oxidative stress, inflammation, and immune injury. Although hyperbaric oxygen therapy is widely used, its efficacy in preventing DNS remains inconclusive. Preclinical and retrospective studies suggest that Dexamethasone (anti-inflammatory and immunosuppressive) and N-acetylcysteine (antioxidant) may reduce DNS risk. This study hypothesizes that their combination can effectively prevent DNS.
Methods: This prospective pre-post intervention study will enroll CO poisoning patients into treatment (Dexamethasone + N-acetylcysteine) and control groups. The primary outcome is the incidence of DNS within six weeks post-treatment.
Objective: To determine whether combining Dexamethasone and N-acetylcysteine reduces the incidence of DNS following CO poisoning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexamethasone and n-acetylcysteine | Experimental | Drug: Dexamethasone and N-acetylcysteine (NAC)Dexamethasone 10mg IV STAT +QD for 3 days+NAC IV 200mg/kg over 4 h, then 100 mg/kg over 16 h |
| placebo | Placebo comparator | Drug: Placebonormal saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- History and clinical symptoms consistent with CO poisoning (initial blood carboxyhemoglobin (COHb) levels >5%, or >10% for smokers).
Key exclusion criteria (1 listed)
- Concurrent use of other potentially lethal toxins. Severe trauma or burns that could be fatal. No spontaneous heartbeat or blood pressure before arrival. Poisoning time exceeding 24 hours before hospital arrival. Minors (under 18 years of age). Pregnant women. Patients or their families refuse to sign the consent form. Contraindications for the use of Dexamethasone or N-acetylcysteine (such as severe allergies) or when the physician assesses the risks outweigh the benefits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone and N-acetylcysteine (NAC)Dexamethasone 10mg IV STAT +QD for 3 days+NAC IV 200mg/kg over 4 hours, then 100 mg/kg over 16 hours | Drug | dexamethasone and n-acetylcysteine |
| PlaceboPlacebo | Drug | placebo |
Primary outcome
Number of participants with delayed neurological sequelae following carbon monoxide exposure, as assessed by clinical evaluation
Time frame: 2 weeks, 6 weeks, 3 months
Questionnaire: Parkinson-like syndromes Concentration deficits Gait and motor disturbances Memory loss Bradykinesia Cognitive impairment Intention tremor Dementia Myoclonus Personality changes Dyspraxia Anxiety Dysphasia Extreme emotional lability Ataxia Psychosis Postural instability Depression Vertigo Mania Cortical blindness Insomnia Hearing loss, tinnitus Chorea EEG abnormalities Epilepsy Peripheral neuropathies Recurrent headaches Fecal or urinary incontinence Criteria: The presence of any delayed-onset symptoms listed above, emerging at least 2 days after initial recovery from carbon monoxide poisoning, will require confirmation by a toxicologist, neurologist, or psychiatrist experienced in diagnosing delayed neuropsychiatric sequelae (DNS) following CO exposure.
1 secondary outcome
Number of participants with cognitive impairment following carbon monoxide exposure, as assessed by the Mini-Mental State Examination (MMSE)
Time frame: 2 weeks, 6 weeks, 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone and N-acetylcysteine (NAC) in people with Carbon Monoxide Poisoning and Delayed Neurocognitive Sequelae, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chi-Syuan Pan (0912697916, miss321@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with delayed neurological sequelae following carbon monoxide exposure, as assessed by clinical evaluation (time frame: 2 weeks, 6 weeks, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.