Prospective Cohort Study of Intravenous Lipid Emulsion for Resuscitating Critically-ill Poisoned Patients

Completed

• Conditions: Overdose

• Registration Number: NCT03107689
• Lead Sponsor: University of Southern California

Brief Summary

The purpose of this project is to evaluate the case characteristics of patients who receive intravenous lipid emulsion therapy. Previous literature to date has focused on animal studies or has been primarily limited to case reports or small case series. This prospectively collected data set will permit a much more detailed description of the use of lipid, its potential benefits, and potential harms.

Detailed Description

The purpose of this project is to evaluate the case characteristics of patients who receive intravenous lipid emulsion therapy. A secondary objective is to determine the mortality in this critically ill population of individuals.

Previous literature to date has focused on animal studies or has been primarily limited to case reports or small case series. This prospectively collected data set will permit a much more detailed description of the use of lipid, its potential benefits, and potential harms.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2016-01-12
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-11
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2023-12
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

• receiving intravenous lipid emulsion for treatment of a drug toxicity
• Evaluation of a medical toxicologist as part of the ToxIC registry consortium

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Exclusion Criteria

• not evaluated by a medical toxicologist participating in ToxIC

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival	Survival is measured at hospital discharge. The study is open to enrollment indefinitely. It is estimated approximately 100 subjects will be enrolled in 5 years	The primary objective is to compare survival based on lipophilicity (as measured by LogD) of the drugs

Trial Locations

Locations (2)

ACMT; ToxIC participating sites; 🇺🇸 Phoenix, Arizona, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States