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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Todd Rice, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00592488
First received: January 2, 2008
Last updated: January 16, 2014
Last verified: January 2014
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Mean Arterial Blood Pressure [ Time Frame: 18 hours ] [ Designated as safety issue: No ]
    Mean Arterial blood pressure measured non-invasively at 18 hours

  • 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 ]

Enrollment: 13
Study Start Date: August 2006
Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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

No publications provided

Responsible Party: Todd Rice, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00592488     History of Changes
Other Study ID Numbers: 050730
Study First Received: January 2, 2008
Results First Received: March 17, 2011
Last Updated: January 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Septic shock
Acetyl-L-carnitine

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Acetylcarnitine
Carnitine
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014