Methylene Blue in Severe Sepsis and Septic Shock

Phase 3

• Conditions: Severe Sepsis; Septic Shock
• Interventions: Drug: Intravenous methylene blue administration; Drug: Placebo

• Registration Number: NCT01797978
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-21
• Study First Submitted QC: 2013-02-22
• Study First Posted: 2013-02-25
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-16
• Last Update Posted: 2015-11-18
• Primary Completion: 2016-01
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 354

Inclusion Criteria

• Septic shock meeting the criteria of 2012 surviving sepsis campaign
• Need the norepinephrine of over 0.2microgram/kg/min

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Exclusion Criteria

• Pregnancy
• Less than 18 years old
• Terminal cancer patients
• Declined consents
• glucose-6-phosphate dehydrogenase deficiency
• Medication of Serotonin modulator

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous methylene blue administration	Intravenous methylene blue administration	2mg/kg IV bolus followed by 0.5mg/kg/hr slow infusion for 6hrs
Placebo	Placebo	Normal saline administration instead of methylene blue

Primary Outcome Measures

Name	Time	Method
28 day mortality	within 28 days of diagnosis

Secondary Outcome Measures

Name	Time	Method
Vasopressor index	with in 28 days of diagnosis
Vasopressor dependent period	within 28 days of diagnosis
Change of cardiac output (CO) and systemic vascular resistance (SVR)	with in 28 days of diagnosis	EV1000 (Edwards inc.) will be used to see the cardiac output and systemic vascular resistance.
Length of stay in ICU (LOSICU)	with in 28 days of diagnosis
LOS in hospital	with in 28 days of diagnosis
In hospital mortality	with in 28 days of diagnosis
Multiple organ failure (SOFA)	with in 28 days of diagnosis
NO level	before and after infusion of MB, 24hrs, 48hrs later
Cytokine level (IL-6, 10, tumor necrosis factor -alpha)	before and after infusion of MB, 24hrs, 48hrs later

Trial Locations

Locations (3)

SMG - SNU Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Kyeongi-do, Korea, Republic of