NCT05148611

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2021

Completed
29 days until next milestone

Study Start

First participant enrolled

November 30, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 8, 2021

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

December 8, 2021

Status Verified

September 1, 2021

Enrollment Period

1 month

First QC Date

November 1, 2021

Last Update Submit

December 2, 2021

Conditions

Keywords

Acute poisoningintravenous lipid emulsion

Outcome Measures

Primary Outcomes (1)

  • mortality rate

    Patient mortality within 24 hours

    24 hours

Secondary Outcomes (2)

  • Circulatory system

    24 hours

  • mortality rate

    1 week and 28 days

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Take the patient's blood for general laboratory tests

Central Study Contacts

yi li, Medical PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2021

First Posted

December 8, 2021

Study Start

November 30, 2021

Primary Completion

December 30, 2021

Study Completion

October 1, 2025

Last Updated

December 8, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share