title: Preliminary safety and efficacy of L-carnitine infusion for the treatment of vasopressor-dependent septic shock: a randomized control trial.
abstract: BACKGROUND
  Sepsis is characterized by metabolic disturbances, and previous data suggest a relative carnitine deficiency may contribute to metabolic dysfunction. Studies regarding safety and patient-centered efficacy of carnitine during septic shock are lacking.
  
  
  METHODS
  This was a double-blind randomized control trial of levocarnitine (L-carnitine) infusion vs normal saline for the treatment of vasopressor-dependent septic shock. Patients meeting consensus definition for septic shock with a cumulative vasopressor index ≥ 3 and sequential organ failure assessment (SOFA) score ≥ 5 enrolled within 16 hours of the recognition of septic shock were eligible. The primary safety outcome was difference in serious adverse events (SAEs) per patient between groups. Efficacy outcomes included proportion of patients demonstrating a decrease in SOFA score of 2 or more points at 24 hours and short- and long-term survival.
  
  
  RESULTS
  Of the 31 patients enrolled, 16 were in the L-carnitine and 15 were in the placebo arm. There was no difference in SAEs between placebo and intervention (2.1 vs 1.8 SAEs per patient, P = .44). There was no difference in the proportion of patients achieving a decrease in SOFA score of 2 or more points at 24 hours between placebo and treatment (53% vs 44%, P = .59). Mortality was significantly lower at 28 days in the L-carnitine group (4/16 vs 9/15, P = .048), with a nonsignificant improved survival at 1 year (P = .06).
  
  
  CONCLUSIONS
  L-carnitine infusion appears safe in vasopressor-dependent septic shock. Preliminary efficacy data suggest potential benefit of L-carnitine treatment, and further testing is indicated.
authors.affiliation: Department of Emergency Medicine, University of Mississippi Medical Center, Jackson.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Puskarich
authors.affiliation: Department of Emergency Medicine, University of Indiana School of Medicine, Indianapolis.
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Kline
authors.affiliation: Department of Emergency Medicine, Carolinas Medical Center, Charlotte, North Carolina.
authors.forename: Virginia
authors.initials: V
authors.lastname: Krabill
authors.affiliation: Department of Emergency Medicine, Carolinas Medical Center, Charlotte, North Carolina.
authors.forename: Heather
authors.initials: H
authors.lastname: Claremont
authors.affiliation: Department of Emergency Medicine, University of Mississippi Medical Center, Jackson aejones@umc.edu.
authors.forename: Alan E
authors.initials: AE
authors.lastname: Jones
mesh_terms: D001741:Black or African American; D000368:Aged; D015992:Body Mass Index; D009202:Cardiomyopathies / Q000188:drug therapy; D002331:Carnitine / Q000172:deficiency / Q000494:pharmacology*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D022124:Hyperammonemia / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D009135:Muscular Diseases / Q000188:drug therapy; D011446:Prospective Studies; D012772:Shock, Septic / Q000188:drug therapy*; D016896:Treatment Outcome; D014662:Vasoconstrictor Agents / Q000494:pharmacology*; D044465:White People
chemical_list: D014662:Vasoconstrictor Agents; D002331:Carnitine
keywords: L-carnitine; carnitine; randomized control trial; sepsis; shock