Completed

RACEPhase 2 Study of Levo-Carnitine for Vasopressor Dependent Septic Shock

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What is being tested

placebo

+ Levo-Carnitine

+ Levo-Carnitine

Drug
Who is being recruted

Infections+5

+ Inflammation

+ Pathologic Processes

Over 18 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: January 2013
See protocol details

Summary

Principal SponsorUniversity of Mississippi Medical Center
Last updated: June 4, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

Prior work has shown that exogenous L-carnitine administration enhances glucose and lactate oxidation, attenuates fatty acid toxicity, and improves endothelial-smooth muscle coupling and cardiac mechanical efficiency. The overall goal of this proposal is to investigate L-carnitine as a novel adjunctive treatment of septic shock. In this study the investigators will test our primary hypothesis: Early adjunctive L-carnitine administration in vasopressor dependent septic shock will significantly reduce cumulative organ failure at 48 hours with an associated decrease in 28-day mortality suggesting the need for further phase III study. To accomplish this the investigators will conduct a phase II, double blinded, placebo controlled, adaptive randomized trial of 250 eligible patients with vasopressor-dependent septic shock. Study subjects will be assigned to one of four arms: low (6g), medium (12g) or high (18g) dose intravenous L-carnitine or placebo for 12 hours as a part of early resuscitative care.

NCT01665092
Principal SponsorUniversity of Mississippi Medical Center
Last updated: June 4, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

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

250 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

InfectionsInflammationPathologic ProcessesShockPathological Conditions, Signs and SymptomsSystemic Inflammatory Response SyndromeSepsisShock, Septic

Criteria

6 inclusion criteria required to participate
Any two of four criteria of systemic inflammatory response as defined by the 2001 ACCP/SCCM Consensus Conference Committee
Blood lactate level of > 2.0 mMol/L
Cumulative sequential organ failure assessment (SOFA) score of >= 6
Recognition of septic shock and initiation of quantitative resuscitation within 24 hours of enrollment
Show More Criteria
12 exclusion criteria prevent from participating
Active Treatment with Coumadin
Active participation in another interventional study
Age < 18 years
Anticipated requirement for surgery that would interfere with the 12 hour infusion time
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
Normal saline

Group II

Experimental
Levo-Carnitine 6g

Group III

Experimental
Levo-Carnitine 12 g

Group IV

Experimental
Levo-Carnitine 18 g

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 14 locations

University of Alabama Birmingham

Birmingham, United StatesOpen University of Alabama Birmingham in Google Maps

Univeristy of California Davis

Sacramento, United States

Christiana Care Health Services

Wilmington, United States

University of Florida

Jacksonville, United States
Completed14 Study Centers