L-Carnitine Administration in Early Sepsis

Phase 1

Terminated

• Conditions: Septic Shock
• Interventions: Drug: L-Carnitine; Drug: Normal Saline

• Registration Number: NCT01193777
• Lead Sponsor: Wake Forest University Health Sciences

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-30
• Study Start: 2010-09
• Study First Submitted QC: 2010-09-01
• Study First Posted: 2010-09-02
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2012-03
• Last Update Submitted: 2022-04-14
• Last Update Posted: 2022-04-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L-Carnitine	L-Carnitine	-
Saline	Normal Saline	-

Primary Outcome Measures

Name	Time	Method
Reduction in organ failure	24 hours	SOFA score will be measured at 0 and 24 hours

Secondary Outcome Measures

Name	Time	Method
Microcirculation	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.
All-cause mortality	12 months
ICU and hospital length of stay	Duration of stay
Change in inflammatory markers	48 hours	Assess change in various inflammatory markers over predefined time points.

Trial Locations

Locations (2)

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States