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NCT03107689 Clinical Trial

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

Overdose Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03107689
Other study ID # HS-13-00634
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2012
Est. completion date December 2018

Study information
Verified date December 2023
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 134
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - receiving intravenous lipid emulsion for treatment of a drug toxicity - Evaluation of a medical toxicologist as part of the ToxIC registry consortium Exclusion Criteria: - not evaluated by a medical toxicologist participating in ToxIC

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• administration of intravenous lipid emulsion
all patients receive intravenous lipid emulsion at the discretion of the treating provider. This registry prospectively collects detailed information on such patients

Locations
Country Name City State
United States University of Southern California Los Angeles California
United States ACMT; ToxIC participating sites Phoenix Arizona

Sponsors (2)
Lead Sponsor Collaborator
University of Southern California American College of Medical Toxicology

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Survival The primary objective is to compare survival based on lipophilicity (as measured by LogD) of the drugs 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
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