L-Carnitine Administration in Early Sepsis
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Septic Shock |
Drug: L-Carnitine Drug: Normal Saline |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
- Reduction in organ failure [ Time Frame: 24 hours ] [ Designated as safety issue: No ]SOFA score will be measured at 0 and 24 hours
- Microcirculation [ Time Frame: 12 hours ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- All-cause mortality [ Time Frame: 28 day ] [ Designated as safety issue: No ]
- All-cause mortality [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- All-cause mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- All-cause mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Change in inflammatory markers [ Time Frame: 12 hours ] [ Designated as safety issue: No ]Assess change in various inflammatory markers over predefined time points.
- Change in inflammatory markers [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Assess change in various inflammatory markers over predefined time points.
- Change in inflammatory markers [ Time Frame: 48 hours ] [ Designated as safety issue: No ]Assess change in various inflammatory markers over predefined time points.
| Enrollment: | 31 |
| Study Start Date: | September 2010 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Saline |
Drug: Normal Saline
Bolus followed by 1 L NS infusion over 12 hours.
|
| Experimental: L-Carnitine |
Drug: L-Carnitine
4 gram bolus followed by 8 gram in 1 L NS infused over 12 hours.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Alan Jones, Professor of Emergency Medicine, University of Mississippi Medical Center |
| ClinicalTrials.gov Identifier: | NCT01193777 History of Changes |
| Other Study ID Numbers: | 04-10-06A, 10POST3560001 |
| Study First Received: | August 30, 2010 |
| Last Updated: | March 8, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Carolinas Healthcare System:
|
Carnitine Shock Sepsis |
Additional relevant MeSH terms:
|
Shock Shock, Septic Pathologic Processes Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation |
Carnitine Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013