Role of Intravenous Lipid Emulsion in Improving Coma of Acute Antipsychotics Poisoning: A Randomized Controlled Trial in PoisonControl Center of Ain Shams University Hospitals
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Complete recovery
研究概览
简要总结
Intravenous Lipid Emulsion in Improving Coma Of Antipsychotic drugs Acute Poisoning: A Randomized Controlled Trial in Poison Control Center of Ain Shams University Hospitals
详细描述
Intravenous lipid emulsions (ILEs) have been recently used in treatment of acute toxicity caused by lipophilic drugs including local anesthetics, antidepressants, anti-arrhythmics, beta blockers and calcium channel antagonists with few case reports concerning their use in treatment of acute antipsychotics overdose (Muller et al., 2015).
To the best of our knowledge, no randomized controlled trials (RCTs) have been performed to evaluate the antidotal effect of ILEs on the level of consciousness of acutely poisoned patients by antipsychotics and their routine metabolic profile tests.
Acute poisoning by antipsychotics could result in various life-threatening toxic effects mainly on cardiovascular and central nervous systems (CNS). Tachycardia, hypotension, and QT prolongation in electrocardiogram are the most common cardiovascular findings while sedation, extrapyramidal symptoms, agitation, and coma are the most common CNS findings following acute antipsychotic exposures (Divac et al., 2014).
As acute antipsychotic drugs overdose lack specific antidote, the primary goal in treatment is aggressive supportive therapy. In order to prevent CNS depression and respiratory failure, patients may need to be supported by mechanical ventilation. Hypotension is treated by intravenous fluids with use of direct-acting vasopressors (Orazel et al., 2019).
Several mechanisms for the antidotal properties of ILEs have been proposed including their ability to capture lipophilic drugs and extract them from vital organs such as the heart and brain thus reducing their toxicity, preferential distribution of lipophilic drugs into a circulating lipid phase, thereby reducing tissue drug concentrations. In addition, ILEs have direct inotropic effect due to improved fatty acid oxidative metabolism resulting in restoration of myocardial contractility (Zyoud et al., 2016 & Kehayova et al., 2019).
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult comatose patients admitted to the ICU of Poison Control Center of Ain Shams University Hospitals with positive history of antisychotic drugs overdose during the period starting from the beginning of March 2020 to the end of Septemper 2021
排除标准
- •Based on the possibility of heterogeneity in hemodynamic parameters, laboratory variables, GCS and/or AVPU Scale, the following patients will be excluded:
- •Patients less than 18 years and more than 65 years.
- •Pregnant and lactating females.
- •Co-ingestion of other agents.
- •Presence of medical diseases (e.g. renal, hepatic, cardiovascular diseases) and chronic pancreatitis.
- •History of head trauma.
- •Presence of conditions where ILE is contraindicated.
研究组 & 干预措施
Group A (control)
Group A (control): that will receive the traditional supportive treatment for acute antipsychotic drugs overdose
干预措施: Intravenous Lipid Emulsion (Intralipid 20%) (Drug)
Group B (case)
that will receive the traditional supportive treatment for acute antipsychotic drugs overdose plus administration of 1.5 ml/kg ILE (20%) as a bolus over 1-2 minutes, followed by a continuous rate infusion of 0.25 ml/kg/min for the next 30 to 60 minutes
干预措施: Intravenous Lipid Emulsion (Intralipid 20%) (Drug)
结局指标
主要结局
Complete recovery
时间窗: 6 months
Regaining consciousness with galasco coma scale 15/15 without presence of other clinical manifestations denoting antipsychotics toxicity.
次要结局
未报告次要终点