L-Carnitine Administration in Early Sepsis
|ClinicalTrials.gov Identifier: NCT01193777|
Recruitment Status : Terminated (Study stopped to open expanded phase II study)
First Posted : September 2, 2010
Last Update Posted : March 9, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Septic Shock||Drug: L-Carnitine Drug: Normal Saline||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Study Start Date :||September 2010|
|Primary Completion Date :||February 2012|
|Study Completion Date :||February 2012|
|Placebo Comparator: Saline||
Drug: Normal Saline
Bolus followed by 1 L NS infusion over 12 hours.
4 gram bolus followed by 8 gram in 1 L NS infused over 12 hours.
- Reduction in organ failure [ Time Frame: 24 hours ]SOFA score will be measured at 0 and 24 hours
- Microcirculation [ Time Frame: 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.
- ICU and hospital length of stay [ Time Frame: Duration of stay ]
- All-cause mortality [ Time Frame: 28 day ]
- All-cause mortality [ Time Frame: 3 months ]
- All-cause mortality [ Time Frame: 6 months ]
- All-cause mortality [ Time Frame: 12 months ]
- Change in inflammatory markers [ Time Frame: 12 hours ]Assess change in various inflammatory markers over predefined time points.
- Change in inflammatory markers [ Time Frame: 24 hours ]Assess change in various inflammatory markers over predefined time points.
- Change in inflammatory markers [ Time Frame: 48 hours ]Assess change in various inflammatory markers over predefined time points.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01193777
|United States, Mississippi|
|University of Mississippi Medical Center|
|Jackson, Mississippi, United States, 39216|
|United States, North Carolina|
|Carolinas Medical Center|
|Charlotte, North Carolina, United States, 28203|
|Principal Investigator:||Alan E Jones, MD||University of Mississippi and Carolinas Medical Center, Department of Emergency Medicine|