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临床试验/NCT05148611
NCT05148611尚未招募不适用

Application Registration Study of ILE in Patients With Acute Poisoning

Peking Union Medical College Hospital0 个研究点目标入组 500 人开始时间: 2021年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
500
主要终点
mortality rate

研究概览

简要总结

In this study, the investigators aimed to study the effect of ILE in the treatment of acute fat-soluble substance poisoning,to further clarify the relevant mechanism of ILE in the treatment of fat-soluble drug poisoning,to standardize the relevant procedures of ILE detoxification treatment and further explore the adverse reactions and coping strategies of ILE treatment.

详细描述

Fat-soluble drugs refer to drugs that are insoluble in water but soluble in fats and organic solvents such as carbon tetrachloride, glycerol, oils and other organic solvents. They can fuse with the phospholipid bilayer of cell membranes, are easily absorbed, and are easier to pass compared to water-soluble drugs. It is metabolized by the liver, and the metabolites are excreted by the kidneys, so it has a high clinical use rate. However, in recent years, due to the improper use of fat-soluble drugs by patients, fat-soluble benzodiazepines sedative and hypnotic drugs, fat-soluble calcium channel blockers and β-blocker drugs, fat-soluble tricyclic drugs have often occurred. Poisoning such as antidepressants poses a serious threat to the lives of patients.In addition, organophosphorus pesticides (fat-soluble) have a high usage rate in China. Severe organophosphorus poisoning can cause multiple organ damages, and delays in treatment can cause disability or even death. Clinical treatment is mainly based on routine gastric lavage and oxygen inhalation. Treatment is the mainstay, combined with medical drugs, hemodialysis, hemoperfusion, etc., and has achieved certain curative effects, but the mortality rate is still high, so it is of great significance to explore safer and more effective treatment methods.Intravenous lipid emulsion (ILE) was originally used to treat overdose of local anesthetics such as bupivacaine, and later also used to treat a variety of other lipophilic drug poisonings. The research on the treatment of ILE is still in the preliminary stage and relatively limited. A systematic review of fat emulsions for the treatment of acute poisoning found that the overall quality of the studies supporting this treatment is low or very low, but the included case reports indicate that fat emulsions are effective against verapamil, beta blockers, and certain Tricyclic antidepressants, bupivacaine, chlorpromazine, and certain antiarrhythmic drugs (eg, flecainide) poisoned patients have certain benefits. ILE may help treat patients who are hemodynamically unstable due to poisoning by these drugs.In view of the fact that the research on the treatment of ILE still needs to be further improved and related adverse reactions need to be further explored related countermeasures, the investigators plan to launch a registration research program related to the application of fat emulsion.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Diagnosed as acute fat-soluble drug and organophosphorus (fat-soluble) pesticide poisoning;
  • Conventional treatment is ineffective, especially for patients with circulatory failure, such as ventricular arrhythmia, shock, cardiac arrest, etc., who need intravenous fat emulsion treatment;
  • Those who are not allergic to fat milk;
  • Sign informed consent.

排除标准

  • Mergers with insufficiency of important organs;
  • Patients with malignant tumors;
  • Severe mental disorder affects the treatment;
  • Those with incomplete clinical data.

结局指标

主要结局

mortality rate

时间窗: 24 hours

Patient mortality within 24 hours

次要结局

  • Circulatory system(24 hours)
  • mortality rate(1 week and 28 days)

研究者

申办方类型
Other
责任方
Sponsor

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