L-Carnitine Administration in Early Sepsis
Primary Purpose
Septic Shock
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
L-Carnitine
Normal Saline
Sponsored by
About this trial
This is an interventional treatment trial for Septic Shock focused on measuring Carnitine, Shock, Sepsis
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
Sites / Locations
- University of Mississippi Medical Center
- Carolinas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Saline
L-Carnitine
Arm Description
Outcomes
Primary Outcome Measures
Reduction in organ failure
SOFA score will be measured at 0 and 24 hours
Secondary Outcome Measures
Microcirculation
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
All-cause mortality
All-cause mortality
All-cause mortality
All-cause mortality
Change in inflammatory markers
Assess change in various inflammatory markers over predefined time points.
Change in inflammatory markers
Assess change in various inflammatory markers over predefined time points.
Change in inflammatory markers
Assess change in various inflammatory markers over predefined time points.
Full Information
NCT ID
NCT01193777
First Posted
August 30, 2010
Last Updated
April 14, 2022
Sponsor
Wake Forest University Health Sciences
Collaborators
American Heart Association
1. Study Identification
Unique Protocol Identification Number
NCT01193777
Brief Title
L-Carnitine Administration in Early Sepsis
Official Title
L-Carnitine Administration in Early Sepsis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Terminated
Why Stopped
Study stopped to open expanded phase II study
Study Start Date
September 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
American Heart Association
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
Carnitine, Shock, Sepsis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Title
L-Carnitine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
L-Carnitine
Intervention Description
4 gram bolus followed by 8 gram in 1 L NS infused over 12 hours.
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
Bolus followed by 1 L NS infusion over 12 hours.
Primary Outcome Measure Information:
Title
Reduction in organ failure
Description
SOFA score will be measured at 0 and 24 hours
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Microcirculation
Description
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.
Time Frame
12 hours
Title
ICU and hospital length of stay
Time Frame
Duration of stay
Title
All-cause mortality
Time Frame
28 day
Title
All-cause mortality
Time Frame
3 months
Title
All-cause mortality
Time Frame
6 months
Title
All-cause mortality
Time Frame
12 months
Title
Change in inflammatory markers
Description
Assess change in various inflammatory markers over predefined time points.
Time Frame
12 hours
Title
Change in inflammatory markers
Description
Assess change in various inflammatory markers over predefined time points.
Time Frame
24 hours
Title
Change in inflammatory markers
Description
Assess change in various inflammatory markers over predefined time points.
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan E Jones, MD
Organizational Affiliation
University of Mississippi and Carolinas Medical Center, Department of Emergency Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26825368
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.
Results Reference
derived
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L-Carnitine Administration in Early Sepsis
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