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

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ClinicalTrials.gov Identifier: NCT00592488
Recruitment Status : Completed
First Posted : January 14, 2008
Results First Posted : June 8, 2011
Last Update Posted : December 8, 2017
Sponsor:
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
A
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
B
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

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

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


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
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
Acetyl-L-carnitine

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