We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Acetyl-L-Carnitine in the Treatment of Septic Shock (ALC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00592488
Recruitment Status : Completed
First Posted : January 14, 2008
Results First Posted : June 8, 2011
Last Update Posted : December 8, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
This placebo-controlled study investigates acetyl-L-carnitine in the treatment of septic shock requiring vasopressors.

Condition or disease Intervention/treatment Phase
Septic Shock Drug: Acetyl-L-Carnitine Phase 1 Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Placebo-controlled, Double-Blinded, Phase II Pilot Study of Acetyl-L-carnitine in the Treatment of Patients With Septic Shock
Study Start Date : August 2006
Primary Completion Date : August 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo for first 6 hours then Acetyl-L-Carnitine (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
Other Name: ALC
Acetyl-L-Carnitine (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
Other Name: ALC

Outcome Measures

Primary Outcome Measures :
  1. Mean Arterial Blood Pressure [ Time Frame: 18 hours ]
    Mean Arterial blood pressure measured non-invasively at 18 hours

Secondary Outcome Measures :
  1. Vasopressor Dose [ Time Frame: 6-24 hours ]
    Change in vasopressor dose between 6 and 24 hours.

  2. Serum Lactate [ Time Frame: 12-36 hours ]
    Latest serum lactate between 12 and 36 hours

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • documented or presumed infection
  • shock requiring vasopressors

Exclusion Criteria:

  • dialysis
  • hepatic failure
  • seizures
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00592488

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Principal Investigator: Todd W. Rice, MD, MSc Vanderbilt University
More Information

Responsible Party: Todd Rice, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00592488     History of Changes
Other Study ID Numbers: 050730
First Posted: January 14, 2008    Key Record Dates
Results First Posted: June 8, 2011
Last Update Posted: December 8, 2017
Last Verified: November 2017

Keywords provided by Todd Rice, Vanderbilt University:
Septic shock

Additional relevant MeSH terms:
Shock, Septic
Pathologic Processes
Systemic Inflammatory Response Syndrome
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Nootropic Agents