A Phase 4 interventional study of Dexamethasone and N-acetylcysteine (NAC) and Placebo in Carbon Monoxide Poisoning and Delayed Neurocognitive Sequelae, sponsored by China Medical University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-26.
Sponsored by China Medical University Hospital · Phase 4, Interventional, and Treatment
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.
44 studies on the registry are indexed under Carbon Monoxide Poisoning; 8 are open to participants now.
This study's planned enrollment of 128 is above the median of 74 across 16 interventional studies indexed under Carbon Monoxide Poisoning.
Browse Carbon Monoxide Poisoning studies →China Medical University Hospital is the lead sponsor of 479 studies on the registry; 115 are open to participants now.
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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)
normal saline
Drug: Placebo
Drug pages: Dexamethasone · Acetylcysteine
Dexamethasone 10mg IV STAT +QD for 3 days+NAC IV 200mg/kg over 4 hours, then 100 mg/kg over 16 hours
Placebo
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.
Time frame: 2 weeks, 6 weeks, 3 months
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.
Time frame: 2 weeks, 6 weeks, 3 months
Plan to share: No
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Started Mar 2025 (actual). Primary completion is estimated for Jun 2027, 27 months after the start.
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Studies of the drugs tested here: Dexamethasone · Acetylcysteine
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