• Critical care medicine · Feb 2016

    Randomized Controlled Trial Multicenter Study

    Randomized, Double-Blind, Placebo-Controlled Trial of Thiamine as a Metabolic Resuscitator in Septic Shock: A Pilot Study.

    • Michael W Donnino, Lars W Andersen, Maureen Chase, Katherine M Berg, Mark Tidswell, Tyler Giberson, Richard Wolfe, Ari Moskowitz, Howard Smithline, Long Ngo, Michael N Cocchi, and Center for Resuscitation Science Research Group.
    • 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.
    • Crit. Care Med. 2016 Feb 1; 44 (2): 360-7.

    ObjectiveTo determine if intravenous thiamine would reduce lactate in patients with septic shock.DesignRandomized, double-blind, placebo-controlled trial.SettingTwo US hospitals.PatientsAdult patients with septic shock and elevated (> 3 mmol/L) lactate between 2010 and 2014.InterventionsThiamine 200 mg or matching placebo twice daily for 7 days or until hospital discharge.Measurements And Main ResultsThe 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).ConclusionAdministration 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.

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