Thiamine Supplementation in Patients With Septic Shock
Thiamine Supplementation in Patients With Septic Shock
To determine if intravenous thiamine would decrease the time to reversal of shock in patients
 with septic shock.
Patients will be randomized to thiamine supplementation or placebo in a 1:1 ratio.
 Randomization will be done by the hospital pharmacy department whom will be the only
 unblinded participants. Patients will receive 200mg thiamine in 50mL of 5% dextrose or
 matching placebo (50mL 5% dextrose) once daily for 7 days or until discharge from the
 intensive care unit. The drug will be mixed by the pharmacy. Administration will be done in
 the patients room in the intensive care unit by the patient's assigned nurse. Blood will be
 collected on admission to the hospital in order to determine baseline lactate level and study
 eligibility. The measurement of lactate is standard of care in patients with sepsis. Thiamine
 level will be collected upon enrollment into the study. The ICU nurse or emergency room nurse
 taking care of the patient at the time of enrollment will draw the blood sample. Standard
 procedure for measuring thiamine levels will be maintained including protecting the blood
 sample from light and keeping it on ice while it is delivered to the lab. Serum lactate will
 be measured daily for 7 days or until discharge from the intensive care unit. The serial
 measurement of serum lactate is considered standard of care in patients with sepsis.
Inclusion Criteria:

 -  Age>18

 -  Sepsis (defined as presence of two or more SIRS criteria with documented or suspected
 infection)

 -  SIRS: Systemic Inflammatory Response Syndrome (SIRS) is the occurrence of at least two
 of the following criteria: temperature >38.0ºC or <36.0ºC, heart rate >90
 beats/minute, respiratory rate >20 breaths/minute, white blood cell count >12,000 or
 <4000.

 -  Lactate >3mmol/L at the time of consent and randomization

 -  Hypotension (systolic blood pressure <90mmHg) after a >2L fluid bolus

 -  Vasopressor dependence (defined as the continuous infusion of norepinephrine,
 dopamine, phenylephrine, vasopressin or epinephrine.)

 Exclusion Criteria:

 -  Known cirrhosis or chronic liver disease

 -  Current thiamine supplementation

 -  Clinical indication for thiamine (e.g. Alcohol abuse)

 -  Comfort measures only designation

 -  Inability to provide consent

 -  Other causes for lactate elevation (seizure, use of medications that can cause lactic
 acidosis such as metformin, linezolid and anti-retrovirals, carbon monoxide, known or
 suspected bowel or limb ischemia, cardiac arrest prior to enrollment)