Clinical trial NCT01193777: L-Carnitine Administration in Early Sepsis
Official title: L-Carnitine Administration in Early Sepsis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Septic Shock
Keywords: Carnitine
Shock
Sepsis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2010-09-02
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Reduction in organ failure
timeFrame: 24 hours
Secondary outcomes:
measure: Microcirculation
timeFrame: 12 hours
measure: ICU and hospital length of stay
timeFrame: Duration of stay
measure: All-cause mortality
timeFrame: 28 day
measure: All-cause mortality
timeFrame: 3 months
measure: All-cause mortality
timeFrame: 6 months
measure: All-cause mortality
timeFrame: 12 months
measure: Change in inflammatory markers
timeFrame: 12 hours
measure: Change in inflammatory markers
timeFrame: 24 hours
measure: Change in inflammatory markers
timeFrame: 48 hours
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: University of Mississippi and Carolinas Medical Center, Department of Emergency Medicine
name: Alan E Jones, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Puskarich MA, Shapiro NI, Massey MJ, Kline JA, Jones AE. Lactate Clearance in Septic Shock Is Not a Surrogate for Improved Microcirculatory Flow. Acad Emerg Med. 2016 Jun;23(6):690-3. doi: 10.1111/acem.12928. Epub 2016 May 11.