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

February 28, 2024 updated by: University of Southern California
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

134

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • ACMT; ToxIC participating sites
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients who receive intravenous lipid emulsion by a toxicologist, participating in the ToxIC registry, who complete the lipid subregistry

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

American College of Medical Toxicology

Investigators

  • Principal Investigator: michael levine, md, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2012

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

January 12, 2016

First Submitted That Met QC Criteria

April 10, 2017

First Posted (Actual)

April 11, 2017

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-13-00634

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Overdose

Clinical Trials on administration of intravenous lipid emulsion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe