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临床试验/NCT04702906
NCT04702906Unknown不适用

Trimetazidine As a Potential Adjuvant Therapy in Acute Aluminum Phosphide Poisoning-induced Cardiotoxicity: A Randomized Controlled Clinical Trial

Tanta University0 个研究点目标入组 40 人开始时间: 2021年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
40
主要终点
Mortality

研究概览

简要总结

The aim of the present study is to evaluate the potential adjuvant therapeutic effect of trimetazidine in treatment of acute AlP poisoning-induced cardiotoxicity.

详细描述

Aluminium phosphide (AlP) is an inorganic phosphide. It is used as a fumigant to protect stored grains from insects, rodents and other pests.It is a solid fumigant widely used in Egypt as a grain preservative. Its tablets are commonly used due to their low cost, high efficacy, and availability .

Toxic effects of AlP are related to phosphine gas release when AlP comes in contact with moisture or gastric acidity. Phosphine gas is rapidly absorbed from the gastrointestinal tract and lungs inhibiting cytochrome-c oxidase and oxidative phosphorylation which results in adenosine triphosphate depletion and resulting cellualr death.

The direct toxic effects of phosphine on cardiac myocytes, fluid loss and adrenal gland can induce profound circulatory collapse. Phosphides and phosphine can exert a direct corrosive effect on body tissues.

Toxic manifestations usually appear rapidly upon phosphide exposure. Impaired myocardial contractility, fluid loss, pulmonary edema, metabolic acidosis and acute renal failure are the most frequent manifestations. Disseminated intravascular coagulation and hepatic necrosis may also occur. Patients generally die due to multi-organ failure .However, myocardial damage- induced cardiovascular collapse is reported to be the primary cause of death.

Severity of manifestations depends on different factors such as dose, exposure route, and time delay before treatment initiation. Diagnosis is based on history of exposure, garlic odor of the breath, suggestive clinical manifestations and detection of phosphine gas in gastric aspirate or breath.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients included in this study will be diagnosed as acute aluminum phosphide poisoning by history and clinical pictures.
  • Age is18 years or older.

排除标准

  • Pregnant and lactating women.
  • Patients with ingestion or exposure to other substances in addition to aluminum phosphide.
  • Patients with other major medical conditions (e.g. cardiovascular disease, diabetes mellitus, renal or hepatic failure).

研究组 & 干预措施

control group

Active Comparator

All patients will continue to receive the standard treatment, which is determined by the attending physician who maintains clinical responsibility for all patients. Conventional standard treatment included using inotropes, fluids and electrolytes resuscitation, intubation, mechanical ventilation, and antiarrhythmic agents if indicated.

干预措施: standard treatment (Other)

trimetazidine group

Active Comparator

The trimetazidine group will receive conventional standard treatment plus Trimetazidine dihydrochloride "metacardia" ® (20 mg three times daily produced by Pharco-Egypt) will be administered twice every 24 hours until at least treatment is no longer needed.

干预措施: standard treatment (Other)

trimetazidine group

Active Comparator

The trimetazidine group will receive conventional standard treatment plus Trimetazidine dihydrochloride "metacardia" ® (20 mg three times daily produced by Pharco-Egypt) will be administered twice every 24 hours until at least treatment is no longer needed.

干预措施: trimetazidine hydrochloride "metacardia" ® 20 mg tablet (Drug)

结局指标

主要结局

Mortality

时间窗: 7 days

mortality rate

次要结局

  • Duration of ventilation(7 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nadia Helal

lecturer

Tanta University

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