The Role of N-acetylcysteine as a Novel Adjuvant Treatment in Acute Organophosphorus.A Randomized, Clinical Trial in Poison Control Center -Ain Shams University Hospitals
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- mortality
研究概览
简要总结
All patients admitted in the ICU of the PCC-ASUH due to acute poisoning by acute organophosphorus poisoning will be included in the study. The diagnosis of intoxication will be based on history of acute exposure , clinical examination and laboratory investigations. Patients will be randomly allocated into 2 equal groups.
Group 1 -. Patients who will receive (conventional treatment of acute organophosphorus poisoning plus NAC) and Group 2 - Patients who will receive conventional treatment only
详细描述
40 patients with acute organophosphorus poisoning will be randomly assigned as control groups and study group in a 1:1 ratio ( 20 patients in each group). The diagnosis of acute organophosphorus intoxication will be based on history of acute exposure, clinical examination and laboratory investigations. Patients will be randomly allocated into 2 equal groups.
Group 1 - Patients who will receive (conventional treatment of acute organophosphorus poisoning plus NAC) Group 2 - Patients who will receive conventional treatment only
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients (above 16 years) admitted to the ICU of the PCC-ASUH due to acute poisoning by acute organophosphorus poisoning will be included in the study. The diagnosis of intoxication will be based on history of acute exposure, clinical examination and laboratory investigations. -
排除标准
- •Based on the possibility of alteration in measured parameters and/or biomarkers, patients below 16 years or above 60 years Patients with history of diabetes, cardiac disease, respiratory, renal disease and hepatic disease.
研究组 & 干预措施
study group
Patients who will receive (conventional treatment of acute organophosphorus poisoning plus NAC)
干预措施: n acetyl cysteine (Drug)
study group
Patients who will receive (conventional treatment of acute organophosphorus poisoning plus NAC)
干预措施: standard treatment (Drug)
control group
Patients who will receive conventional treatment only
干预措施: standard treatment (Drug)
结局指标
主要结局
mortality
时间窗: 72 hours
次要结局
未报告次要终点
研究者
Sarah Saeed Mohammed
lecturer of clinical toxicology
Ain Shams University