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临床试验/NCT03953248
NCT03953248已完成早期 1 期

L-Carnitine as an Adjuvant Treatment in Acute Phosphide Poisoning (LC): A Randomized Clinical Trial

Heba Allah Ali Abd El-Halim Mabrouk0 个研究点目标入组 50 人开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
50
主要终点
Mortality

研究概览

简要总结

The aim of this study was to evaluate efficacy and safety of Alpha Lipoic Acid(ALA) as an adjuvant in the management of patients with acute phosphide poisoning.

详细描述

The study was carried out following approval of the research ethical committee of Tanta Faculty of Medicine on patients admitted to The Poison Control Unit (Emergency Hospitals, Tanta and Mansoura Universities) with acute phosphide poisoning in the period from January 2016 to January 2018. A written informed consent was taken from each patient or his/her guardians (if the patient was unable to participate in the consent process). Confidentiality of the data was maintained by making code numbers for each patient. The investigators planned to conduct a randomized clinical trial to evaluate efficacy and safety of LC as an adjuvant in treatment of patients with acute phosphide poisoning. Fifty patients was randomized to LC or a non LC in a 1:1 ratio (25 patients in each group). LC was given IV, as a dose of 1 g/8 hours. Patients was monitored and a detailed documentation of any adverse effect due to LC therapy was recorded.

This intervention represented an added treatment to the existing standard of care. All patients will continue to receive standard treatment, which was determined by the attending physician who maintained clinical responsibility for all patients. It consisted of patient resuscitation, gastric decontamination (with sodium bicarbonate, and activated charcoal [1 g/Kg, orally] in the first 6 hours after onset of poisoning), adequate hydration and supportive treatment. All the patients was followed up until discharge or death. All patients was subjected to:

I. History. II. Clinical examination. III. Laboratory investigations: At admission and repeated before discharge.

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
Single (Participant)

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients (male or female, aged 12 years or older) with symptomatic acute phosphide poisoning (deliberate or accidental), with diagnosis made on the basis of:
  • The typical clinical manifestations due to and following shortly after a single exposure to phosphide.
  • Reliable identification of the compound based on the container brought by patient attendants or a subsequent confirmation by silver nitrate test for phosphine detection in stomach contents.

排除标准

  • Patients less than 12 years of age Pregnant and lactating women Patients with ingestion or exposure to other substances in addition to phosphide.
  • Patients with other major medical conditions (e.g. cardiovascular disease, renal or hepatic failure).
  • Patients presenting more than 6 hours of having consumed the phosphide compound (late presenters).
  • Patients treated for acute phosphide poisoning in any medical center before admission

研究组 & 干预措施

L-Carnitine

Active Comparator

Subjects in this arm will receive standard treatment in addition to LC IV, as a dose of 1 g/8 hours

干预措施: L-Carnitine (Drug)

结局指标

主要结局

Mortality

时间窗: 2 years

Death Rate

次要结局

  • Duration of hospital stay(2 years)

研究者

发起方
Heba Allah Ali Abd El-Halim Mabrouk
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Heba Allah Ali Abd El-Halim Mabrouk

Principal Investigator

Kafrelsheikh University

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