title: Thiamine as an adjunctive therapy in cardiac surgery: a randomized, double-blind, placebo-controlled, phase II trial.
abstract: BACKGROUND
  Thiamine is a vitamin that is essential for adequate aerobic metabolism. The objective of this study was to determine if thiamine administration prior to coronary artery bypass grafting would decrease post-operative lactate levels as a measure of increased aerobic metabolism.
  
  
  METHODS
  We performed a randomized, double-blind, placebo-controlled trial of patients undergoing coronary artery bypass grafting. Patients were randomized to receive either intravenous thiamine (200 mg) or placebo both immediately before and again after the surgery. Our primary endpoint was post-operative lactate levels. Additional endpoints included pyruvate dehydrogenase activity, global and cellular oxygen consumption, post-operative complications, and hospital and intensive care unit length of stay.
  
  
  RESULTS
  Sixty-four patients were included. Thiamine levels were significantly higher in the thiamine group as compared to the placebo group immediately after surgery (1200 [683, 1200] nmol/L vs. 9 [8, 13] nmol/L, p < 0.001). There was no difference between the groups in the primary endpoint of lactate levels immediately after the surgery (2.0 [1.5, 2.6] mmol/L vs. 2.0 [1.7, 2.4], p = 0.75). Relative pyruvate dehydrogenase activity was lower immediately after the surgery in the thiamine group as compared to the placebo group (15% [11, 37] vs. 28% [15, 84], p = 0.02). Patients receiving thiamine had higher post-operative global oxygen consumption 1 hour after the surgery (difference: 0.37 mL/min/kg [95% CI: 0.03, 0.71], p = 0.03) as well as cellular oxygen consumption. We found no differences in clinical outcomes.
  
  
  CONCLUSIONS
  There were no differences in post-operative lactate levels or clinical outcomes between patients receiving thiamine or placebo. Post-operative oxygen consumption was significantly increased among patients receiving thiamine.
  
  
  BACKGROUND
  clinicaltrials.gov NCT02322892, December 14, 2014.
authors.affiliation: Center for Resuscitation Science, Department of Emergency Medicine, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA, 02215, USA. lwanders@bidmc.harvard.edu.|Department of Anesthesiology, Aarhus University Hospital, Nørrebrogade 44, 8000, Aarhus C, Denmark. lwanders@bidmc.harvard.edu.|Research Center for Emergency Medicine, Aarhus University Hospital, Nørrebrogade 44, 8000, Aarhus C, Denmark. lwanders@bidmc.harvard.edu.
authors.forename: Lars W
authors.initials: LW
authors.lastname: Andersen
authors.affiliation: Center for Resuscitation Science, Department of Emergency Medicine, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA, 02215, USA.|Research Center for Emergency Medicine, Aarhus University Hospital, Nørrebrogade 44, 8000, Aarhus C, Denmark.
authors.forename: Mathias J
authors.initials: MJ
authors.lastname: Holmberg
authors.affiliation: Department of Medicine, Division of Pulmonary and Critical Care, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA, 02215, USA.
authors.forename: Katherine M
authors.initials: KM
authors.lastname: Berg
authors.affiliation: Center for Resuscitation Science, Department of Emergency Medicine, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA, 02215, USA.
authors.forename: Maureen
authors.initials: M
authors.lastname: Chase
authors.affiliation: Center for Resuscitation Science, Department of Emergency Medicine, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA, 02215, USA.|Department of Anesthesia Critical Care, Division of Critical Care, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA, 02215, USA.
authors.forename: Michael N
authors.initials: MN
authors.lastname: Cocchi
authors.affiliation: Center for Resuscitation Science, Department of Emergency Medicine, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA, 02215, USA.
authors.forename: Christopher
authors.initials: C
authors.lastname: Sulmonte
authors.affiliation: Center for Resuscitation Science, Department of Emergency Medicine, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA, 02215, USA.
authors.forename: Julia
authors.initials: J
authors.lastname: Balkema
authors.affiliation: Center for Resuscitation Science, Department of Emergency Medicine, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA, 02215, USA.
authors.forename: Mary
authors.initials: M
authors.lastname: MacDonald
authors.affiliation: Center for Resuscitation Science, Department of Emergency Medicine, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA, 02215, USA.
authors.forename: Sophia
authors.initials: S
authors.lastname: Montissol
authors.affiliation: Department of Surgery, Division of Cardiothoracic Surgery, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA, 02215, USA.
authors.forename: Venkatachalam
authors.initials: V
authors.lastname: Senthilnathan
authors.affiliation: Department of Surgery, Division of Cardiothoracic Surgery, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA, 02215, USA.
authors.forename: David
authors.initials: D
authors.lastname: Liu
authors.affiliation: Department of Surgery, Division of Cardiothoracic Surgery, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA, 02215, USA.
authors.forename: Kamal
authors.initials: K
authors.lastname: Khabbaz
authors.affiliation: Department of Anesthesia, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA, 02215, USA.
authors.forename: Adam
authors.initials: A
authors.lastname: Lerner
authors.affiliation: Clinical Research Center, Soroka University Medical Center, POB 151, Beer-Sheva, 84965, Israel.|Faculty of Health Sciences, Ben-Gurion University, POB 151, Beer-Sheva, 84965, Israel.
authors.forename: Victor
authors.initials: V
authors.lastname: Novack
authors.affiliation: Center for Resuscitation Science, Department of Emergency Medicine, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA, 02215, USA.
authors.forename: Xiaowen
authors.initials: X
authors.lastname: Liu
authors.affiliation: Center for Resuscitation Science, Department of Emergency Medicine, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA, 02215, USA.|Department of Medicine, Division of Pulmonary and Critical Care, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA, 02215, USA.
authors.forename: Michael W
authors.initials: MW
authors.lastname: Donnino
mesh_terms: D000368:Aged; D001026:Coronary Artery Bypass / Q000379:methods* / Q000401:mortality; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D019344:Lactic Acid / Q000097:blood; D008297:Male; D010101:Oxygen Consumption / Q000187:drug effects; D011183:Postoperative Complications / Q000517:prevention & control*; D013831:Thiamine / Q000008:administration & dosage / Q000494:pharmacology* / Q000627:therapeutic use*
chemical_list: D019344:Lactic Acid; D013831:Thiamine
keywords: Aerobic; Anaerobic; Cardiac surgery; Coronary artery bypass grafting; Lactate; Metabolism; Oxygen consumption; Pyruvate dehydrogenase; Thiamine