drugset / Trial / NCT06811675

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

NCT06811675

Phase 4 Recruiting 128 enrolled China Medical University Hospital
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 10 mg Intravenous
Subject N-acetylcysteine Small molecule 100 mg/kg Intravenous