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

• Sponsor: University of Southern California (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03107689
• Collaborator: American College of Medical Toxicology (Other)
• Enrollment: 100
• Locations: 2
• Duration (Months): 68
• Patients Per Site: 50
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overdose	Other: administration of intravenous lipid emulsion

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 Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective Cohort Study of Intravenous Lipid Emulsion for Resuscitating Critically-ill Poisoned Patients
• Study Start Date: May 1, 2012
• Anticipated Primary Completion Date: Dec 1, 2017
• Anticipated Study Completion Date: Jan 1, 2018

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ACMT; ToxIC participating sites	Phoenix	Arizona	United States	85006
2	University of Southern California	Los Angeles	California	United States	90033

Sponsors and Collaborators

• University of Southern California
• American College of Medical Toxicology

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Levine, Assistant professor of emergency medicine, University of Southern California
• ClinicalTrials.gov Identifier: NCT03107689
• Other Study ID Numbers: HS-13-00634
• First Posted: Apr 11, 2017
• Last Update Posted: Apr 11, 2017
• Last Verified: Jan 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Michael Levine, Assistant professor of emergency medicine, University of Southern California: ILE; lipid; overdose; resuscitation
• Additional relevant MeSH terms: Drug Overdose; Fat Emulsions, Intravenous

Study Results

No Results Posted as of Apr 11, 2017