L-Carnitine Administration in Early Sepsis

Study Overview
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Brief Summary
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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.

Official Title
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L-Carnitine Administration in Early Sepsis

Conditions
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Septic Shock

Intervention / Treatment
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* Drug: L-Carnitine
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Saline<br> | Drug: Normal Saline<br>* Bolus followed by 1 L NS infusion over 12 hours.<br>|
| Experimental: L-Carnitine<br> | Drug: L-Carnitine<br>* 4 gram bolus followed by 8 gram in 1 L NS infused over 12 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in organ failure | SOFA score will be measured at 0 and 24 hours | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 hours | 
| ICU and hospital length of stay |  | Duration of stay | 
| All-cause mortality |  | 28 day | 
| All-cause mortality |  | 3 months | 
| All-cause mortality |  | 6 months | 
| All-cause mortality |  | 12 months | 
| Change in inflammatory markers | Assess change in various inflammatory markers over predefined time points. | 12 hours | 
| Change in inflammatory markers | Assess change in various inflammatory markers over predefined time points. | 24 hours | 
| Change in inflammatory markers | Assess change in various inflammatory markers over predefined time points. | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carnitine, Shock, Sepsis