Comparative Effectiveness of N-acetyl Cysteine, Acetyl L- Carnitine and Medicated Paraffin Oil in Acute Aluminium Phosphide Poisoning: A Clinical Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- mortality rate reduction
研究概览
简要总结
Aluminium Phosphide is a pesticide used in developing countries to prevent rodents and pests from spoiling the harvested grains. it is presented as tablets which can be administered accidently to humans or for committing suicide. this pesticide is fatal even in small concentration as mortality rate can reach 75- 100% of cases. in this study researchers tried to add some supplements to the routine treatment to improve and decrease the fatality rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients with history of acute intoxication with AlP presented to the Poison Control Center of Ain-Shams University hospitals during the period of the study
排除标准
- •Patients less than 18
- •Patients presented with delay time exceeding 12 hours after acute intoxication.
- •Patients with history of cardiac, renal or hepatic diseases.
- •Patients who show hypersensitivity to NAC, ALCAR or paraffin oil.
研究组 & 干预措施
control group
this group will have the standard and routine therapy of treatment of acute Aluminium Phosphide poisoning immediately after admission according to PCCA guidelines
干预措施: Sodium Bicarbonate Powder and ondansetron (Drug)
N- acetyl cysteine grouo
N-acetyl cysteine will be given at dose of 300mg/kg/d IV in the first day then 150 mg/kg/d IV in addition to standard of care according to PCCA guidelines
干预措施: N-acetyl cysteine (Drug)
N- acetyl cysteine grouo
N-acetyl cysteine will be given at dose of 300mg/kg/d IV in the first day then 150 mg/kg/d IV in addition to standard of care according to PCCA guidelines
干预措施: Sodium Bicarbonate Powder and ondansetron (Drug)
Acetyl L-carnitine group
Acetyl L-carnitine will be given at dose of 50 mg/kg IV once to be followed by additional doses of 15 mg/kg IV q4hr infused over 30 min. standard of care according to PCCA guidelines will also be provided
干预措施: acetyl L-carnitine (Dietary Supplement)
Acetyl L-carnitine group
Acetyl L-carnitine will be given at dose of 50 mg/kg IV once to be followed by additional doses of 15 mg/kg IV q4hr infused over 30 min. standard of care according to PCCA guidelines will also be provided
干预措施: Sodium Bicarbonate Powder and ondansetron (Drug)
Medicated paraffin oil group
Gastric decontamination with sodium bicarbonate (NaHCO3; 44 mEq, orally) and medicated paraffin oil (200 mL) will be administered in addition to standard of care according to PCCA guidelines
干预措施: medicated paraffin oil (Drug)
Medicated paraffin oil group
Gastric decontamination with sodium bicarbonate (NaHCO3; 44 mEq, orally) and medicated paraffin oil (200 mL) will be administered in addition to standard of care according to PCCA guidelines
干预措施: Sodium Bicarbonate Powder and ondansetron (Drug)
结局指标
主要结局
mortality rate reduction
时间窗: 1 year
the primary end point is to lower the mortality rate for patients poisoned with aluminium phosphide pellets
organ damage reduction
时间窗: 1 year
another primary end point is to reduce organ damage and injury for survivors
次要结局
未报告次要终点
研究者
Dalia K. Zaafar
lecturer of pharmacology
Cairo University