Role of Intralipid in Management of Organophosphorus Poisoning
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 60
- 主要终点
- duration in days of hospitalization and ICU stay
研究概览
简要总结
Aim of the study:
To assess the role of intralipid emulsion in the acute man-agement of organophosphorus toxicity and its benefits in de-creasing mortality rates among victims.
详细描述
Organophosphates (OPs) are cholinesterase inhibitors that are widely used as pesticides and organophosphate (OP) poisoning is an important public health concern in Egypt especially in the rural farming population. Organophosphate toxicity lead to a characteristic toxidrome that includes muscarinic, nicotinic and central nervous system signs and symptoms and, without proper and early antidotal treatment, death. A new antidote is the need of the hour. Lipid emulsion being inexpensive, easily available and effective in management of other lipid soluble toxins may be a novel option. The exact mechanisms by which ILE exert their beneficial effects are not fully understood, and several have suggested synergistic effects of several mechanisms. The mechanisms of action can be divided into intravascular, membrane, and intracellular effects. The original theory explaining the mechanism of lipid rescue was that of "lipid sink", suggesting sequestration of lipophilic compounds to an expanded intravascular lipid phase, extracting the offending agent from the target tissue, and reversing the toxicity. Other hypotheses relate to the mechanism by which ILEs facilitate cardiac rescue from drug poisoning. These include:
- increasing myocardial energy substrate delivery and a direct cardiotonic effect of ILE on the poisoned heart.
- an effect of ILE on calcium ion channels through high levels of long-chain fatty acids, leading to increased cardiomyocyte calcium and positive inotropic effect.
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 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age group of 18-60 years who are exposed to organophosphorus compounds.
- •Clinical manifestations of organophosphorus toxidromes (hyper-salivation, lacrimation, sweating, urinary incontinence, di-arrhea, vomiting and abdominal pain).
排除标准
- •Patient or relative in charge refusal.
- •Chronic renal or liver disease manifested by history, clinical and investigatory diagnosis.
- •Previous history of acute or chronic pancreatitis
- •Combined poisoning with non OP compounds
- •Asymptomatic patients.
- •Contraindications to intralipid emulsion as:
- •disturbances of normal fat metabolism such as patho-logic hyperlipemia manifested by history, clinical and investigatory diagnosis.
- •lipoid nephrosis manifested by history, clinical and investigatory diagnosis.
研究组 & 干预措施
Follow up
Follow Up of 30 patients after administration of atropine.
干预措施: Intravenous Atropine Sulfate (Drug)
intralipid 20% adjuvant
30 patients will receive atropine and intralipid AS AN ADJUVANT Three boluses of IFE 15 mg/kg were given over 3 minutes, 20 minutes apart.
干预措施: Intralipid, 20% Intravenous Emulsion (Drug)
intralipid 20% adjuvant
30 patients will receive atropine and intralipid AS AN ADJUVANT Three boluses of IFE 15 mg/kg were given over 3 minutes, 20 minutes apart.
干预措施: Intravenous Atropine Sulfate (Drug)
结局指标
主要结局
duration in days of hospitalization and ICU stay
时间窗: four days
The primary outcome is to study the difference in total days of hospitalization and ICU stay between the study and control groups.
次要结局
- mortality.(four days)
研究者
Amani Hassan Abdel-Wahab
Professor of anesthesia and intensive care
Assiut University
