title: Randomized, Double-Blind, Placebo-Controlled Trial of Thiamine as a Metabolic Resuscitator in Septic Shock: A Pilot Study.
abstract: OBJECTIVE
  To determine if intravenous thiamine would reduce lactate in patients with septic shock.
  
  
  METHODS
  Randomized, double-blind, placebo-controlled trial.
  
  
  METHODS
  Two US hospitals.
  
  
  METHODS
  Adult patients with septic shock and elevated (> 3 mmol/L) lactate between 2010 and 2014.
  
  
  METHODS
  Thiamine 200 mg or matching placebo twice daily for 7 days or until hospital discharge.
  
  
  RESULTS
  The primary outcome was lactate levels 24 hours after the first study dose. Of 715 patients meeting the inclusion criteria, 88 patients were enrolled and received study drug. There was no difference in the primary outcome of lactate levels at 24 hours after study start between the thiamine and placebo groups (median: 2.5 mmol/L [1.5, 3.4] vs. 2.6 mmol/L [1.6, 5.1], p = 0.40). There was no difference in secondary outcomes including time to shock reversal, severity of illness and mortality. 35% of the patients were thiamine deficient at baseline. In this predefined subgroup, those in the thiamine treatment group had statistically significantly lower lactate levels at 24 hours (median 2.1 mmol/L [1.4, 2.5] vs. 3.1 [1.9, 8.3], p = 0.03). There was a statistically significant decrease in mortality over time in those receiving thiamine in this subgroup (p = 0.047).
  
  
  CONCLUSIONS
  Administration of thiamine did not improve lactate levels or other outcomes in the overall group of patients with septic shock and elevated lactate. In those with baseline thiamine deficiency, patients in the thiamine group had significantly lower lactate levels at 24 hours and a possible decrease in mortality over time.
authors.affiliation: 1Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, MA. 2Department of Medicine, Division of Pulmonary and Critical Care, Beth Israel Deaconess Medical Center, Boston, MA. 3Department of Anesthesiology, Aarhus University Hospital, Aarhus, Denmark. 4Department of Medicine, Division of Pulmonary and Critical Care, Baystate Medical Center, MA. 5Department of Medicine, Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Boston, MA. 6Department of Emergency Medicine, Baystate Medical Center, MA. 7Department of Anesthesia Critical Care, Division of Critical Care, Beth Israel Deaconess Medical Center, Boston, MA.
authors.forename: Michael W
authors.initials: MW
authors.lastname: Donnino
authors.forename: Lars W
authors.initials: LW
authors.lastname: Andersen
authors.forename: Maureen
authors.initials: M
authors.lastname: Chase
authors.forename: Katherine M
authors.initials: KM
authors.lastname: Berg
authors.forename: Mark
authors.initials: M
authors.lastname: Tidswell
authors.forename: Tyler
authors.initials: T
authors.lastname: Giberson
authors.forename: Richard
authors.initials: R
authors.lastname: Wolfe
authors.forename: Ari
authors.initials: A
authors.lastname: Moskowitz
authors.forename: Howard
authors.initials: H
authors.lastname: Smithline
authors.forename: Long
authors.initials: L
authors.lastname: Ngo
authors.forename: Michael N
authors.initials: MN
authors.lastname: Cocchi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D019344:Lactic Acid / Q000097:blood*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012720:Severity of Illness Index; D012772:Shock, Septic / Q000097:blood* / Q000188:drug therapy* / Q000453:epidemiology; D013831:Thiamine / Q000627:therapeutic use*; D013832:Thiamine Deficiency / Q000188:drug therapy* / Q000453:epidemiology
chemical_list: D019344:Lactic Acid; D013831:Thiamine