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Infusion of Methylene Blue in Severe Sepsis and Septic Shock: Randomized, Double

Phase 3
18 Years
Not Enrolling
Severe Sepsis, Septic Shock

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Trial Information

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

Inclusion Criteria:

- Septic shock meeting the criteria of 2012 surviving sepsis campaign

- Need the norepinephrine of over 0.2microgram/kg/min

Exclusion Criteria:

- Pregnancy

- Less than 18 years old

- Immunosuppressant patients (e.g. on steroid medication, active anti-cancer
chemotherapeutic agent, etc.)

- Declined consents

- glucose-6-phosphate dehydrogenase deficiency

- Medication of Serotonin modulator

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

28 day mortality

Outcome Time Frame:

within 28 days of diagnosis

Safety Issue:


Principal Investigator

Kyuseok Kim, MD

Investigator Role:

Study Director

Investigator Affiliation:

Professor, department of emergency medicine


Korea: Food and Drug Administration

Study ID:




Start Date:

February 2013

Completion Date:

March 2016

Related Keywords:

  • Severe Sepsis
  • Septic Shock
  • Sepsis
  • Septic shock
  • Methylene blue
  • Sepsis
  • Toxemia
  • Shock
  • Shock, Septic