Methylene Blue in Severe Sepsis and Septic Shock

Seoul National University

Status and phase: Unknown; Phase 3

Conditions: Severe Sepsis; Septic Shock

Treatments: Drug: Placebo; Drug: Intravenous methylene blue administration

Study type: Interventional

Funder types: Other

Identifiers

NCT01797978

B-1210/173-002

Details and patient eligibility

About

This study is to see whether the intravenous administration of methylene blue improves the outcome in severe sepsis and septic shock.

Full description

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 shock.

Enrollment: 354 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Terminal cancer patients
• Declined consents
• glucose-6-phosphate dehydrogenase deficiency
• Medication of Serotonin modulator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

354 participants in 2 patient groups, including a placebo group

Intravenous methylene blue administration

Experimental group

Description:

2mg/kg IV bolus followed by 0.5mg/kg/hr slow infusion for 6hrs

Treatment:

Drug: Intravenous methylene blue administration

Placebo

Placebo Comparator group

Description:

Normal saline administration instead of methylene blue

Treatment:

Drug: Placebo