NCT06811675 The Efficacy of Dexamethasone in Combination With N-acetylcysteine in Preventing Neurocognitive Sequelae Due to Carbon Monoxide Poisoning
| NCT ID | NCT06811675 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | China Medical University Hospital |
| Condition | Carbon Monoxide Poisoning |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2025-03-23 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 128 participants in total. It began in 2025-03-23 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * History and clinical symptoms consistent with CO poisoning (initial blood carboxyhemoglobin (COHb) levels \>5%, or \>10% for smokers). Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06811675 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Carbon Monoxide Poisoning. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06811675 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06811675 currently recruiting?
Yes, NCT06811675 is actively recruiting participants. Contact the research team at miss321@gmail.com for enrollment information.
Where is the NCT06811675 trial being conducted?
This trial is being conducted at Taichung, Taiwan.
Who is sponsoring the NCT06811675 clinical trial?
NCT06811675 is sponsored by China Medical University Hospital. The trial plans to enroll 128 participants.