Assessing The Role Of Intravenous Lipid Emulsion As A Life Saving Therapy In Pesticides Toxicity: A Randomized Controlled Trial In Poison Control Center Of Ain Shams University Hospitals
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- mortality rate reduction
研究概览
简要总结
Intravenous lipid emulsion is an established, effective treatment for local anesthetic systemic toxicity. It is also efficacious in animal models of severe cardiotoxicity caused by a number of other medications. Recent case reports of successful resuscitation suggest the efficacy of lipid emulsion infusion for treating non-local anesthetic overdoses across a wide spectrum of drugs. The present study will focus on the potential role of intravenous lipid emulsion as an adjuvant therapy in pesticides toxicity.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute pesticide intoxications with poison severity score 2 or 3 admitted in ICU of PCC-ASUH
排除标准
- •Patients less than 18 years and more than 65 years.
- •Pregnant and lactating females.
- •Presence of medical diseases (e.g. renal, hepatic, cardiovascular, neurological diseases and chronic pancreatitis.)
- •Allergy to soya-, egg-or peanut protein
研究组 & 干预措施
control group
will receive the traditional supportive treatment according to (PCC-ASUH) protocol
干预措施: Atropine (Drug)
control group
will receive the traditional supportive treatment according to (PCC-ASUH) protocol
干预措施: Toxogonin (Drug)
control group
will receive the traditional supportive treatment according to (PCC-ASUH) protocol
干预措施: Sodium Bicarbonate Powder and ondansetron (Drug)
case group
will receive the traditional supportive treatment plus administration of ILE (20%) 1.5 ml/kg as a bolus over 2-3 minutes. Followed immediately by an infusion of 20 % lipid emulsion at a rate of 0.25 mL/kg/min. After 3 minutes of this infusion rate, response to the bolus and initial infusion should be assessed. If there has been a significant response, the infusion rate can be adjusted to 0.025 mL/kg/min with monitoring of blood pressure, heart rate, and other available hemodynamic parameters during the infusion with a maximum dose of 10 mL/kg
干预措施: Lipid Emulsion, Intravenous (Drug)
case group
will receive the traditional supportive treatment plus administration of ILE (20%) 1.5 ml/kg as a bolus over 2-3 minutes. Followed immediately by an infusion of 20 % lipid emulsion at a rate of 0.25 mL/kg/min. After 3 minutes of this infusion rate, response to the bolus and initial infusion should be assessed. If there has been a significant response, the infusion rate can be adjusted to 0.025 mL/kg/min with monitoring of blood pressure, heart rate, and other available hemodynamic parameters during the infusion with a maximum dose of 10 mL/kg
干预措施: Atropine (Drug)
case group
will receive the traditional supportive treatment plus administration of ILE (20%) 1.5 ml/kg as a bolus over 2-3 minutes. Followed immediately by an infusion of 20 % lipid emulsion at a rate of 0.25 mL/kg/min. After 3 minutes of this infusion rate, response to the bolus and initial infusion should be assessed. If there has been a significant response, the infusion rate can be adjusted to 0.025 mL/kg/min with monitoring of blood pressure, heart rate, and other available hemodynamic parameters during the infusion with a maximum dose of 10 mL/kg
干预措施: Toxogonin (Drug)
case group
will receive the traditional supportive treatment plus administration of ILE (20%) 1.5 ml/kg as a bolus over 2-3 minutes. Followed immediately by an infusion of 20 % lipid emulsion at a rate of 0.25 mL/kg/min. After 3 minutes of this infusion rate, response to the bolus and initial infusion should be assessed. If there has been a significant response, the infusion rate can be adjusted to 0.025 mL/kg/min with monitoring of blood pressure, heart rate, and other available hemodynamic parameters during the infusion with a maximum dose of 10 mL/kg
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 pesticides
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
Aya Sabry Mohamed Mohamed
Assistant lecturer of forensic medicine and clinical toxicology department faculty of medicine Ain shams university
Ain Shams University