NCT01797978

Methylene Blue in Severe Sepsis and Septic Shock

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 354 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Severe Sepsis
• Septic Shock

Interventions

Type	Name	Description
DRUG	Intravenous methylene blue administration	Initial history taking and physical examination --\> enrollment --\> 2mg/kg IV bolus followed by 0.5mg/kg/hr slow infusion of methylene blue for 6hrs
DRUG	Placebo

Timeline

• Start date: 2013-02-01
• Primary completion: 2016-01-01
• Completion: 2017-03-01
• First posted: 2013-02-25
• Last updated: 2015-11-18

Locations

3 sites across 1 country: South Korea