L-Carnitine Administration in Early Sepsis

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. Identifier: NCT01193777
Recruitment Status : Terminated (Study stopped to open expanded phase II study)
First Posted : September 2, 2010
Last Update Posted : March 9, 2012
American Heart Association
Information provided by (Responsible Party):
Alan Jones, University of Mississippi Medical Center

Brief Summary:

Sepsis is a severe and overwhelming response to an infection in the body. Over 750,000 patients in the United States develop sepsis every year. As sepsis becomes progressively more severe, a patient's blood pressure drops to dangerous levels and the body cannot pump oxygen to the rest of the body, which is necessary for normal cell function. This is called septic shock. When someone develops septic shock, it is very common for the smallest blood vessels in the body called the microcirculation to clog, like a highway during rush hour. Even with the best medical care, more than one in three patients with septic shock will die.

The major goal of this study is to test if intravenous replacement of a naturally occurring nutrient that is lost by the body during sepsis called L-carnitine can reduce how sick a patient with sepsis becomes. In our study, some patients will receive L-carnitine and others will receive saline. We will measure markers determining severity of illness in both groups and compare them to see if L-carnitine helps patients get better faster. Based on research already conducted, we believe L-carnitine will improve blood flow in the microcirculation, delivering more oxygen to cells, and help the body get better. To test if this is true, we will directly look at the microcirculation under the tongue with a special magnifying camera that looks at red blood cells, and compare both groups.

Condition or disease Intervention/treatment Phase
Septic Shock Drug: L-Carnitine Drug: Normal Saline Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock

Arm Intervention/treatment
Placebo Comparator: Saline Drug: Normal Saline
Bolus followed by 1 L NS infusion over 12 hours.

Experimental: L-Carnitine Drug: L-Carnitine
4 gram bolus followed by 8 gram in 1 L NS infused over 12 hours.

Primary Outcome Measures :
  1. Reduction in organ failure [ Time Frame: 24 hours ]
    SOFA score will be measured at 0 and 24 hours

Secondary Outcome Measures :
  1. Microcirculation [ Time Frame: 12 hours ]
    Test if carnitine improves blood flow in the sublingual microvasculature during septic shock by performing sidestream dark-field (SDF) video-microscopy of the sublingual microcirculation, prior to and after 12 hours of carnitine infusion.

  2. ICU and hospital length of stay [ Time Frame: Duration of stay ]
  3. All-cause mortality [ Time Frame: 28 day ]
  4. All-cause mortality [ Time Frame: 3 months ]
  5. All-cause mortality [ Time Frame: 6 months ]
  6. All-cause mortality [ Time Frame: 12 months ]
  7. Change in inflammatory markers [ Time Frame: 12 hours ]
    Assess change in various inflammatory markers over predefined time points.

  8. Change in inflammatory markers [ Time Frame: 24 hours ]
    Assess change in various inflammatory markers over predefined time points.

  9. Change in inflammatory markers [ Time Frame: 48 hours ]
    Assess change in various inflammatory markers over predefined time points.

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Suspected or confirmed infection
  • Any two of four criteria of systemic inflammatory response
  • Requirement for vasopressors to treat shock
  • Enrollment within 12 hours of vasopressor initiation
  • SOFA score of greater than or equal to 5 at the time of enrollment

Exclusion Criteria:

  • Age <18 years
  • Pregnancy or breastfeeding
  • Any primary diagnosis other than sepsis
  • Established Do Not Resuscitate status or advanced directives restricting aggressive care or treating physician deems aggressive care unsuitable
  • Any history of seizures or a known seizure disorder
  • Any known inborn error of metabolism
  • Anticipated requirement for surgery that would interfere with the 12 hour infusion time
  • Active participation in another interventional study
  • Inability to obtain informed consent
  • Cardiopulmonary resuscitation (chest compression or defibrillation) prior to enrollment
  • Known systemic allergy to carnitine

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 identifier (NCT number): NCT01193777

United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
Carolinas Healthcare System
American Heart Association
Principal Investigator: Alan E Jones, MD University of Mississippi and Carolinas Medical Center, Department of Emergency Medicine

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Alan Jones, Professor of Emergency Medicine, University of Mississippi Medical Center Identifier: NCT01193777     History of Changes
Other Study ID Numbers: 04-10-06A
10POST3560001 ( Other Grant/Funding Number: American Heart Association )
First Posted: September 2, 2010    Key Record Dates
Last Update Posted: March 9, 2012
Last Verified: March 2012

Keywords provided by Alan Jones, University of Mississippi Medical Center:

Additional relevant MeSH terms:
Shock, Septic
Systemic Inflammatory Response Syndrome
Pathologic Processes