Alpha Lipoic Acid as an Adjuvant Treatment in Acute Phosphide Poisoning: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 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 is 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 will be carried out following approval of the research ethical committee of Tanta Faculty of Medicine on patients admitted to The Poison Control Unit (Emergency Hospital, Tanta University and Emergency Hospital, Mansoura University) with acute phosphide poisoning in the period from January 2016 to January 2018. A written informed consent will be taken from each patient or his/her guardians (if the patient was unable to participate in the consent process). Confidentiality of the data will be maintained by making code numbers for each patient. The investigators plan to conduct a randomized clinical trial to evaluate efficacy and safety of ALA as an adjuvant in treatment of patients with acute phosphide poisoning. Fifty patients will be randomized to ALA or a non ALA in a 1:1 ratio (25 patients in each group). ALA will be given IV, as a dose of 600 mg/12 hours. Patients will be monitored and a detailed documentation of any adverse effect due to ALA therapy will be recorded.
This intervention represents an added treatment to the existing standard of care. All patients will continue to receive standard treatment, which is determined by the attending physician who maintains clinical responsibility for all patients. It consists 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 will be followed up until discharge or death. All patients will be 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
- 否
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
Alpha Lipoic Acid
Subjects in this arm will receive ALA IV, as a dose of 600 mg/12 hours.
干预措施: Alpha Lipoic Acid (Thioctacid) (Drug)
Non-Alpha Lipoic Acid
Subjects in this arm will to receive standard treatment only (without Alpha Lipoic Acid, instead they will receive placebo , which is determined by the attending physician who maintains clinical responsibility for all patients. It consists 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.
干预措施: Placebo (for Alpha Lipoic Acid) (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
Heba Allah Ali Abd El-Halim Mabrouk
Principal Investigator
Kafrelsheikh University