L-Carnitine Administration in Early Sepsis
Information source: Carolinas Healthcare System
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Septic Shock
Intervention: L-Carnitine (Drug); Normal Saline (Drug)
Phase: Phase 1
Status: Terminated
Sponsored by: Carolinas Healthcare System Official(s) and/or principal investigator(s): Alan E Jones, MD, Principal Investigator, Affiliation: University of Mississippi and Carolinas Medical Center, Department of Emergency Medicine
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.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Reduction in organ failure
Secondary outcome: MicrocirculationICU and hospital length of stay All-cause mortality All-cause mortality All-cause mortality All-cause mortality Change in inflammatory markers Change in inflammatory markers Change in inflammatory markers
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
University of Mississippi Medical Center, Jackson, Mississippi 39216, United States
Carolinas Medical Center, Charlotte, North Carolina 28203, United States
Additional Information
Starting date: September 2010
Last updated: March 8, 2012
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