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Not yet recruitingNCT05148611ILEUpdated Dec 8, 2021

Application Registration Study of ILE in Patients With Acute Poisoning

An observational study in Acute Poisoning, sponsored by Peking Union Medical College Hospital. Not yet recruiting. Per ClinicalTrials.gov, last updated 2021-12-08.

Sponsored by Peking Union Medical College Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2021, 4 years 9 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Sex
All
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Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Acute Poisoning

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Keywords

  • Acute poisoning
  • intravenous lipid emulsion
03

In context

Poisoning

209 studies on the registry are indexed under Poisoning; 26 are open to participants now.

This study's planned enrollment of 500 is above the median of 121 across 94 observational studies indexed under Poisoning.

Browse Poisoning studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

Study population

According to the indications of ILE in the treatment of poisoning in clinical toxicology, the research objects are divided into the following categories:

  1. Calcium channel blocker poisoning
  2. Beta blocker drug poisoning
  3. Tricyclic antidepressant poisoning
  4. Organophosphorus (fat-soluble) pesticide poisoning, such as: chlorpyrifos, profenofos, diazinon, fenthion, phosphaphos, quinalphos, butylpyrimidin, thiazophos, omethoate, dimethoate Methionine, triazophos, thiomethionine, ethion, sulfoxiphos, imiphos, fosfoxcarb, pyrifoxaphos, hydrocarbophos, phorate, methyl parathion, parasulfur Phosphorus, dichlorvos, pyridoxine, etc.
  5. Local anesthetic poisoning
  6. Poisoning by other fat-soluble substances

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Mergers with insufficiency of important organs;
  2. Patients with malignant tumors;
  3. Severe mental disorder affects the treatment;
  4. Those with incomplete clinical data.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
1 Month
Patient registry
Yes
Biospecimen retention
Samples without dna
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What researchers measure

Primary outcomes

  1. mortality rate

    Patient mortality within 24 hours

    Time frame: 24 hours

Secondary outcomes

  1. Circulatory system

    Circulation stabilization time: including blood pressure stabilization time, disappearance time of malignant arrhythmia, etc.

    Time frame: 24 hours

  2. mortality rate

    1 week and 28 days patient mortality

    Time frame: 1 week and 28 days

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Study locations

No study locations are listed for this record.

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References and documents

Study documents

  • Study protocol · Nov 12, 2021
  • Informed consent form · Nov 12, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05148611
Lead sponsor
Peking Union Medical College Hospital
Collaborators
The Affiliated Hospital of Qingdao University, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, People's Hospital of Deyang City, Binzhou Medical University, People's Hospital of Zhengzhou University
Responsible party
Sponsor
First posted
Dec 8, 2021
Start date
Nov 30, 2021 (estimated)
Primary completion
Dec 30, 2021 (estimated)
Completion
Oct 1, 2025 (estimated)
Last update
Dec 8, 2021

Study contacts

yi li, Medical PhD
Contact
qmbb719@163.com
15098750165

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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