Thiamine as a Renal Protective Agent in Septic Shock

This is a randomized, double-blind, placebo controlled study to investigate the effect of
intravenous thiamine (vitamin B1) on renal injury in septic shock. Patients admitted with
septic shock who have a lactate of at least 2.0mmol/L and do not have pre-existing renal
failure requiring dialysis will be eligible for the study. Enrolled patients will be
randomized to intravenous thiamine 200mg twice daily for 6 doses or matching placebo. Blood
will be drawn at several time points to assess biomarkers of renal injury. Secondary
endpoints include need for renal replacement therapy, length of ICU stay, and hospital
mortality.

Inclusion Criteria:

1. Adult ≥18 years of age

2. Suspected or Confirmed Infection (defined as collection of a blood/fluid culture and
provision of an antimicrobial)

3. Receipt of a vasopressor agent (e.g. norepinephrine, phenylephrine, vasopressin)

4. Serum lactate ≥2mmol/L

5. Creatinine >1.0mg/dL

Exclusion Criteria:

1. Clinical indication for thiamine administration (alcoholism, known or highly suspected
deficiency) or treatment with thiamine beyond the amount found in a standard
multivitamin within the last 10 days

2. Renal replacement therapy within the past 30 days

3. Comfort measures only or anticipated withdrawal of support within 24 hours

4. Protected populations (pregnant women, prisoners)

5. Known thiamine allergy