L-Carnitine Administration in Early Sepsis

NCT01193777 | Terminated Phase 1 DMC

• 2 other identifiers: 04-10-06A10POST3560001
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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

Keywords

Carnitine; Shock; Sepsis

Outcome Measures

Primary Outcomes (1)

• Reduction in organ failure

  SOFA score will be measured at 0 and 24 hours

  24 hours

Secondary Outcomes (9)

• Microcirculation

  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

Study Arms (2)

Saline

PLACEBO COMPARATOR

Drug: Normal Saline

L-Carnitine

EXPERIMENTAL

Drug: L-Carnitine

Interventions

L-Carnitine DRUG

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

L-Carnitine

Normal Saline DRUG

Bolus followed by 1 L NS infusion over 12 hours.

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• American Heart Association: collaborator

Study Sites (2)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Related Publications (1)

• 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.

  PMID: 26825368 DERIVED

MeSH Terms

Conditions

Shock, Septic; Shock; Sepsis

Interventions

Carnitine; Saline Solution

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Alan E Jones, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2010
• First Posted: September 2, 2010
• Study Start: September 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: April 22, 2022

Record last verified: 2012-03

Locations

US (2)