L-Carnitine Administration in Early Sepsis

Septic Shock Clinical Trial

Official title:

L-Carnitine Administration in Early Sepsis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01193777
• Other study ID #: 04-10-06A
• Secondary ID: 10POST3560001
• Status: Terminated
• Phase: Phase 1
• Start date: September 2010
• Est. completion date: February 2012

Study information

• Verified date: March 2012
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Septic Shock

Intervention

Drug:
• L-Carnitine
4 gram bolus followed by 8 gram in 1 L NS infused over 12 hours.
• Normal Saline
Bolus followed by 1 L NS infusion over 12 hours.

Locations

Country	Name	City	State
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in organ failure	SOFA score will be measured at 0 and 24 hours	24 hours
Secondary	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
Secondary	ICU and hospital length of stay		Duration of stay
Secondary	All-cause mortality		28 day
Secondary	All-cause mortality		3 months
Secondary	All-cause mortality		6 months
Secondary	All-cause mortality		12 months
Secondary	Change in inflammatory markers	Assess change in various inflammatory markers over predefined time points.	12 hours
Secondary	Change in inflammatory markers	Assess change in various inflammatory markers over predefined time points.	24 hours
Secondary	Change in inflammatory markers	Assess change in various inflammatory markers over predefined time points.	48 hours