Randomized, Double-Blind, Placebo-Controlled Trial of Thiamine as a Metabolic Resuscitator in Septic Shock

Abstract

Objective To determine if intravenous thiamine would reduce lactate in patients with septic shock. Design Randomized, double-blind, placebo-controlled trial. Setting Two US hospitals. Patients Adult patients with septic shock and elevated (> 3 mmol/L) lactate between 2010 and 2014. Interventions Thiamine 200 mg or matching placebo twice daily for 7 days or until hospital discharge. Measurements and Main 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). Conclusion 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.

Commentary: Thiamine Deficiency in Tropical Pediatrics: New Insights into a Neglected but Vital Metabolic Challenge

“…In a randomized controlled trial by Donnino et al, thiamine administration did not improve lactate levels or clinical outcomes in adults with septic shock the overall group. However, it is noteworthy that in those with baseline TD, patients in the thiamine-supplemented group had lower serum lactate at 24 h and in-hospital mortality (21). Further studies are necessary to determine which groups of patients are expected to benefit from this intervention.…”

Сепсис: Традиції Та Інновації В Термінології, Патогенезі, Діагностиці, Інтенсивній Терапії — Заради Врятування Та Збереження Життя Хворого

“…Еюнальный доступ не снижает объем доставки энергии, не снижает частоту ВАП, но частота малых гастроинтестинальных кровотечений выше, чем при гастральном доступе. Следовательно, рутинное применение не рекомендуется [24].…”

Nutrition Therapy in Sepsis

“…New data indicate that thiamine deficiency occurs in up to 35% of septic shock patients [53]. A recent randomized, double-blind, controlled trial showed that administration of 200 mg thiamine to patients with septic shock did not improve lactate levels or other outcomes overall [53].…”