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

China Medical University

Status and phase: Enrolling; Phase 4

Conditions: Carbon Monoxide Poisoning; Delayed Neurocognitive Sequelae

Treatments: Drug: Placebo; Drug: Dexamethasone and N-acetylcysteine (NAC)

Study type: Interventional

Funder types: Other

Identifiers

NCT06811675

CMUH113-REC1-201

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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128 participants in 2 patient groups, including a placebo group

dexamethasone and n-acetylcysteine

Experimental group

Description:

Dexamethasone 10mg IV STAT +QD for 3 days+NAC IV 200mg/kg over 4 h, then 100 mg/kg over 16 h

Treatment:

Drug: Dexamethasone and N-acetylcysteine (NAC)

placebo

Placebo Comparator group

Description:

normal saline

Treatment:

Drug: Placebo