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
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, see Learn About Clinical Studies.

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
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014