Acetyl-L-Carnitine in the Treatment of Septic Shock - Full Text View

Sponsored by:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00592488

Purpose

This placebo-controlled study investigates acetyl-L-carnitine in the treatment of septic shock requiring vasopressors.

Condition	Intervention	Phase
Septic Shock	Drug: Acetyl-L-Carnitine	Phase I Phase II

Drug Information available for: Carnitine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Prospective, Randomized, Placebo-Controlled, Double-Blinded, Phase II Pilot Study of Acetyl-L-Carnitine in the Treatment of Patients With Septic Shock

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

mean arterial blood pressure [ Time Frame: 24-36 hours ] [ Designated as safety issue: No ]
vasopressor dose [ Time Frame: 6-24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

serum lactate [ Time Frame: 12-36 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	16
Study Start Date:	August 2006
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A Placebo for first 6 hours then ALC for 12 hours	Drug: Acetyl-L-Carnitine Acetyl-L-Carnitine - 4 g IV over 30 minutes, then 8 g iv over the next 12 hours
B ALC for first 12 hours then placebo for next 6 hours	Drug: Acetyl-L-Carnitine Acetyl-L-Carnitine - 4 g IV over 30 minutes, then 8 g iv over the next 12 hours

Detailed Description:

This is a cross-over study which infuses ALC for 12 out of 18 hours (and placebo the other 6). Patients must have vasopressor-dependent septic shock and be free from renal failure, hepatic failure, and seizures to be eligible.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

documented or presumed infection
shock requiring vasopressors

Exclusion Criteria:

dialysis
hepatic failure
seizures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592488

Contacts

Contact: Todd W Rice, MD, MSc

(615) 322-3412

todd.rice@vanderbilt.edu

Locations

United States, Tennessee
Vanderbilt University Medical Center	Recruiting
Nashville, Tennessee, United States, 37232
Contact: Todd W. Rice, MD, MSc 615-322-3412 todd.rice@vanderbilt.edu

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator:

Todd W. Rice, MD, MSc

Vanderbilt University

More Information

No publications provided

Responsible Party:	Vanderbilt University ( Todd W. Rice, MD, MSc )
Study ID Numbers:	050730
Study First Received:	January 2, 2008
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00592488 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vanderbilt University:

Septic shock
Acetyl-L-carnitine

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Nootropic Agents
Sepsis
Vitamin B Complex
Shock
Vitamins

Shock, Septic
Trace Elements
Micronutrients
Carnitine
Acetylcarnitine
Inflammation

Additional relevant MeSH terms:

Systemic Inflammatory Response Syndrome
Nootropic Agents
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Infection
Pharmacologic Actions
Inflammation
Sepsis

Pathologic Processes
Shock
Vitamins
Therapeutic Uses
Shock, Septic
Micronutrients
Central Nervous System Agents
Carnitine
Acetylcarnitine

ClinicalTrials.gov processed this record on May 07, 2009