L-Carnitine Administration in Early Sepsis

NCT ID: NCT01193777

Last Updated: 2022-04-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-02-29

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 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.

Conditions

Septic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Saline

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: DRUG

Bolus followed by 1 L NS infusion over 12 hours.

L-Carnitine

Group Type: EXPERIMENTAL

L-Carnitine

Intervention Type: DRUG

4 gram bolus followed by 8 gram in 1 L NS infused over 12 hours.

Interventions

L-Carnitine

4 gram bolus followed by 8 gram in 1 L NS infused over 12 hours.

Intervention Type: DRUG

Normal Saline

Bolus followed by 1 L NS infusion over 12 hours.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alan E Jones, MD

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi and Carolinas Medical Center, Department of Emergency Medicine

Locations

University of Mississippi Medical Center

Jackson, Mississippi, United States

Carolinas Medical Center

Charlotte, North Carolina, United States

Countries

United States

References

Puskarich MA, Shapiro NI, Massey MJ, Kline JA, Jones AE. Lactate Clearance in Septic Shock Is Not a Surrogate for Improved Microcirculatory Flow. Acad Emerg Med. 2016 Jun;23(6):690-3. doi: 10.1111/acem.12928. Epub 2016 May 11.

Reference Type: DERIVED

PMID: 26825368 (View on PubMed)

Other Identifiers

10POST3560001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

04-10-06A

Identifier Type: -

Identifier Source: org_study_id