NCT03107689

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2012

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

May 1, 2012

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2016

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 1, 2024

Status Verified

December 1, 2023

Enrollment Period

6.6 years

First QC Date

January 12, 2016

Last Update Submit

February 28, 2024

Conditions

Overdose

Keywords

ILElipidoverdoseresuscitation

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

administration of intravenous lipid emulsionOTHER

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • not evaluated by a medical toxicologist participating in ToxIC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ACMT; ToxIC participating sites

Phoenix, Arizona, 85006, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Drug Overdose

Condition Hierarchy (Ancestors)

Prescription Drug MisuseDrug MisuseSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • michael levine, md

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2016

First Posted

April 11, 2017

Study Start

May 1, 2012

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 1, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(2)