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临床试验/NCT04724655
NCT04724655已完成早期 1 期

Gastric Lavage With Paraffin Oil or Coconut Oil in Management of Acute Aluminum Phosphide Poisoning: A Randomized Controlled Clinical Trial.

Tanta University1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2021年1月1日最近更新:
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
入组人数
89
试验地点
1
主要终点
death

研究概览

简要总结

The aim of the present study is to evaluate safety and efficacy of gastric lavage with paraffin oil or gastric lavage with coconut oil in management of acute Aluminum phosphide poisoning.

详细描述

60 patients will be randomly assigned as control groups, paraffin group, and coconut group in a 1:1:1 ratio (30 patients in each group).

Inclusion criteria:

  • Patients with symptomatic acute aluminum phosphide poisoning
  • Age is more than 12 years of both gender
  • Patients presenting within 6 hours post-ingestion of aluminum phosphide (Papade and Vanjari, 2019).

The diagnosis is made on the basis of:

  1. The suggestive clinical manifestations due to and following shortly after a single exposure to aluminum phosphide.
  2. Reliable identification of the compound based on the container brought by patient attendants.
  3. Biochemical detection of phosphine gas in gastric aspirate (silver nitrate test).

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, Investigator)

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 with symptomatic acute aluminum phosphide poisoning
  • Age is more than 12 years of both gender
  • Patients presenting within 6 hours post-ingestion of aluminum phosphide

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 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

Other

gastric lavage with saline and bicarbonate and standard treatment :inotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate

干预措施: standard treatment (Drug)

control group

Other

gastric lavage with saline and bicarbonate and standard treatment :inotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate

干预措施: gastric lavage with saline and bicarbonate (Other)

paraffin group

Active Comparator

gastric lavage with paraffin oil and bicarbonate and standard treatment :inotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate

干预措施: gastric lavage with paraffin oil and bicarbonate (Other)

paraffin group

Active Comparator

gastric lavage with paraffin oil and bicarbonate and standard treatment :inotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate

干预措施: standard treatment (Drug)

coconut group

Active Comparator

gastric lavage with coconut oil and bicarbonate and standard treatment :inotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate

干预措施: gastric lavage with coconut oil and bicarbonate (Other)

coconut group

Active Comparator

gastric lavage with coconut oil and bicarbonate and standard treatment :inotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate

干预措施: standard treatment (Drug)

结局指标

主要结局

death

时间窗: 72 hours

次要结局

未报告次要终点

研究者

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

samah maher

faculty of medicine,tanta university,Tanta Elgeesh street,qism 2,Egypt

Tanta University

研究点 (1)

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