To determine if intravenous thiamine
would reduce lactate
in patients with septic shock
Randomized, double-blind, placebo-controlled trial.
Two US hospitals.
Adult patients with septic shock
and elevated (> 3 mmol/L) lactate
between 2010 and 2014.
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).
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.