L-Carnitine Administration in Early Sepsis

This study has been terminated.
(Study stopped to open expanded phase II study)
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Alan Jones, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT01193777
First received: August 30, 2010
Last updated: March 8, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Septic Shock
Drug: L-Carnitine
Drug: Normal Saline
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Carolinas Healthcare System:

Primary Outcome Measures:
  • Reduction in organ failure [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    SOFA score will be measured at 0 and 24 hours


Secondary Outcome Measures:
  • Microcirculation [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    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.

  • ICU and hospital length of stay [ Time Frame: Duration of stay ] [ Designated as safety issue: No ]
  • All-cause mortality [ Time Frame: 28 day ] [ Designated as safety issue: No ]
  • All-cause mortality [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • All-cause mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • All-cause mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in inflammatory markers [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    Assess change in various inflammatory markers over predefined time points.

  • Change in inflammatory markers [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Assess change in various inflammatory markers over predefined time points.

  • Change in inflammatory markers [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Assess change in various inflammatory markers over predefined time points.


Enrollment: 31
Study Start Date: September 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01193777

Locations
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
Investigators
Principal Investigator: Alan E Jones, MD University of Mississippi and Carolinas Medical Center, Department of Emergency Medicine
  More Information

No publications provided

Responsible Party: Alan Jones, Professor of Emergency Medicine, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT01193777     History of Changes
Other Study ID Numbers: 04-10-06A, 10POST3560001
Study First Received: August 30, 2010
Last Updated: March 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Carolinas Healthcare System:
Carnitine
Shock
Sepsis

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

ClinicalTrials.gov processed this record on October 23, 2014