Preliminary safety and efficacy of L-carnitine infusion for the treatment of vasopressor-dependent septic shock: A randomized control trial

Michael A. Puskarich, Jeffrey Kline, Virginia Krabill, Heather Claremont, Alan E. Jones

Research output: Contribution to journalArticle

16 Citations (Scopus)

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). Conclusion: 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.

Original languageEnglish
Pages (from-to)736-743
Number of pages8
JournalJournal of Parenteral and Enteral Nutrition
Volume38
Issue number6
DOIs
StatePublished - 2014

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Carnitine
Septic Shock
Safety
Organ Dysfunction Scores
Placebos
Therapeutics
Survival
Patient Safety
Sepsis
Mortality

Keywords

  • carnitine
  • L-carnitine
  • randomized control trial
  • sepsis
  • shock

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Nutrition and Dietetics

Cite this

Preliminary safety and efficacy of L-carnitine infusion for the treatment of vasopressor-dependent septic shock : A randomized control trial. / Puskarich, Michael A.; Kline, Jeffrey; Krabill, Virginia; Claremont, Heather; Jones, Alan E.

In: Journal of Parenteral and Enteral Nutrition, Vol. 38, No. 6, 2014, p. 736-743.

Research output: Contribution to journalArticle

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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). Conclusion: 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.",
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N2 - 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). Conclusion: 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.

AB - 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). Conclusion: 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.

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