Impact of Combining N-acetylcysteine Intravenous Infusion and Intralipid Emulsion Infusion Versus Intralipid Infusion Alone on Myocardial Injury in Aluminum Phosphide Toxicity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 58
- 主要终点
- Echocardiography
研究概览
简要总结
Assess impact of ILE and NAC in morbidity and mortality when used as adjuvant therapy to routine management of acute ALP poisoning.
详细描述
Aluminum phosphide (ALP) is one of the solid fumigant pesticides. In Egypt, ALP is extensively used to protect grains against insects and rodents. It is available in the form of tablets known as "grain tablet". Suicidal ingestion of ALP tablets is obviously increasing in developing countries. This is attributed to its wide use, free availability in the market, and its low cost.
Aluminum phosphide toxicity is extremely fatal. The conveyed mortality rate differs from 37-100%. More than 90% of patients die within the first 24 hours, mainly due to cardiac dysrhythmia. Despite continuous research, no effective antidote has been reported for this lethal poisoning so far. PH3 is phosphorus trihydride and solubility of phosphorus can affect PH3. Solubilities of phosphorus are as follows: In water: 1 part/300,000 parts water; in absolute alcohol: 1 g/400 mL. One gram phosphorus dissolves in 80 ml olive oil, 60 ml oil of turpentine, and about 100 mL of almond oil. So, PH3 might also have lipid soluble property and used IV lipid emulsion may counter its effects.
Intravenous lipid emulsion (ILE) is a sterile fat emulsion prepared for intravenous administration as a source of calories and essential fatty acids. Its main components include up to 20% soybean oil, 1.2% egg yolk phospholipids, 2.25% glycerin, and water for injection. In addition, sodium hydroxide has been added to adjust the pH, so that the final pH is 8.
Based on animal models and clinical studies, ILE is an established antidote for local-anesthetic drugs systemic toxicity. Besides, ILE has been well used for resuscitation of severe toxicities caused by various lipophilic non-local anesthetic drugs.
N-acetylcysteine (NAC) is a well-studied compound which is commonly used in the treatment of paracetamol poisoning. It has shown to replenish cellular glutathione stores in addition to the strong antioxidant properties. NAC has shown to reduce mortality, hospitalization time, and need for mechanical ventilation in ALP poisoning. A cohort study by Agarwal reported survival benefit in patients who received treatment with NAC compared to the control group.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presentation with symptomatic acute ALP poisoning.
- •History of exposure including reliable identification of the compound based on the container brought by patient's relatives.
- •The suggestive clinical manifestations following shortly after a single exposure to ALP.
排除标准
- •Co-ingestion or exposure to other substances in addition to ALP.
- •Patients had major medical conditions (e.g., cardiovascular disease, renal or hepatic failure).
- •Patients received treatment in any hospital or medical center before admission - other than emergency department of Assiut University Hospital.
研究组 & 干预措施
N-acetyl cysteine (NAC)
Conservative management + ILE infusion 10 ml/hr + N-acetyl cysteine (NAC) infusion 150 mg/kg body weight in 200 ml of 5% dextrose over 1 h, followed by 50 mg/kg body weight in 500 ml of 5% dextrose over 4 h, and then 100 mg/kg body weight in 1000 ml of 5% dextrose over 16 h.
干预措施: N-acetyl cysteine (Drug)
结局指标
主要结局
Echocardiography
时间窗: 24 hours
Follow up cardiac function by echocardiography focusing on LV EF
次要结局
- Renal function test(24 hours)
- Total days of ICU stay(Up to two weeks)
研究者
Tassbeeh Kamal
Principal Investigator
Assiut University