Status:
TERMINATED
L-Carnitine Administration in Early Sepsis
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
American Heart Association
Conditions:
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01193777
Start Date
September 1 2010
End Date
February 1 2012
Last Update
April 22 2022
Active Locations (2)
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1
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
2
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203