Acute PoisoningILENCT05148611
Application Registration Study of ILE in Patients With Acute Poisoning
An observational study of Acute Poisoning, run by Peking Union Medical College Hospital.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Poisoning
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2021to 1 Oct 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Mergers with insufficiency of important organs;
- Patients with malignant tumors;
- Severe mental disorder affects the treatment;
- Those with incomplete clinical data.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Acute Poisoning
- Keywords
- Acute poisoning, intravenous lipid emulsion
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality rate
Patient mortality within 24 hours
Measured: 24 hours
Secondary outcomes (2)
Circulatory system
Circulation stabilization time: including blood pressure stabilization time, disappearance time of malignant arrhythmia, etc.
Measured: 24 hours
mortality rate
1 week and 28 days patient mortality
Measured: 1 week and 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start30 Nov 2021 (estimated)
- Primary completion30 Dec 2021 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PoisoningStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148611
- Sponsor's protocol ID
- ZS-3185D
- Acronym
- ILE
- Status last verified
- Sep 2021
- First submitted
- 1 Nov 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application Registration Study of ILE in Patients With Acute Poisoning
- ClinicalTrials.gov ID
- NCT05148611
- Acronym / sponsor ID
- ILE / ZS-3185D
- Conditions
- Acute Poisoning
- Keywords
- Acute poisoning, intravenous lipid emulsion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- 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
- Study start
- 30 Nov 2021 (estimated)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Mergers with insufficiency of important organs;
- Patients with malignant tumors;
- Severe mental disorder affects the treatment;
- Those with incomplete clinical data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mortality rate
Time frame: 24 hours
Patient mortality within 24 hours
2 secondary outcomes
Circulatory system
Time frame: 24 hours
mortality rate
Time frame: 1 week and 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Poisoning, run by Peking Union Medical College Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yi li, Medical PhD (15098750165, qmbb719@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality rate (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021; AzTrials last refreshed its copy on 7 Nov 2026.