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

March 23, 2025 updated by: China Medical University Hospital

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taichung, Taiwan, 404022
        • Recruiting
        • China Medical University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
normal saline
Drug: Placebo
Placebo
Experimental: dexamethasone and n-acetylcysteine
Dexamethasone 10mg IV STAT +QD for 3 days+NAC IV 200mg/kg over 4 h, then 100 mg/kg over 16 h
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks, 6 weeks, 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
2 weeks, 6 weeks, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

February 3, 2025

First Submitted That Met QC Criteria

February 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 23, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH113-REC1-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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