Infusion of Methylene Blue in Severe Sepsis and Septic Shock: Randomized, Double
The mortality of septic shock is still high ranging from 30 to 50%. Vasopressor is the main
part in managing septic shock, but the choice of vasopressor is still under-investigated,
and area of uncertainty.
The response to vasopressor is sometimes unsatisfactory, and in that case, the outcome of
the patients is poor.
Recently, small size clinical trial has investigated the effect of methylene blue (MB), and
showed promising results. However, large sized phase III trial has not been performed yet.
Large sized phase III clinical trial is needed to establish the effect of MB in septic
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
28 day mortality
within 28 days of diagnosis
Kyuseok Kim, MD
Professor, department of emergency medicine
Korea: Food and Drug Administration