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The Efficacy of Dexamethasone in Combination With N-acetylcysteine in Preventing Neurocognitive Sequelae Due to Carbon Monoxide Poisoning

NCT06811675 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2025-03-26

No results posted yet for this study

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.

Conditions

  • Carbon Monoxide Poisoning
  • Delayed Neurocognitive Sequelae

Interventions

DRUG

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

Placebo

Placebo

Sponsors & Collaborators

  • China Medical University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-23
Primary Completion
2027-06-30
Completion
2027-09-30

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06811675 on ClinicalTrials.gov