Methylene Blue in Severe Sepsis and Septic Shock

Sponsor

Seoul National University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01797978

Collaborator

(none)

354

Enrollment

Locations

Arms

48.9

Duration (Months)

118

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Severe Sepsis Septic Shock	Drug: Intravenous methylene blue administration Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

354 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2013

Anticipated Primary Completion Date :

Jan 1, 2016

Anticipated Study Completion Date :

Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intravenous methylene blue administration 2mg/kg IV bolus followed by 0.5mg/kg/hr slow infusion for 6hrs	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 Other Names: methylene blue administration MB administration
Placebo Comparator: Placebo Normal saline administration instead of methylene blue	Drug: Placebo

Arm

Intervention/Treatment

Experimental: Intravenous methylene blue administration

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

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

Other Names:

methylene blue administration

MB administration

Placebo Comparator: Placebo

Normal saline administration instead of methylene blue

Drug: Placebo

Outcome Measures

Primary Outcome Measures

28 day mortality [within 28 days of diagnosis]

Secondary Outcome Measures

Vasopressor dependent period [within 28 days of diagnosis]
Vasopressor index [with in 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country
1	Seoul National University Bundang Hospital	Seongnam-si	Kyeongi-do	Korea, Republic of
2	Seoul National University Hospital	Seoul		Korea, Republic of
3	SMG - SNU Boramae Medical Center	Seoul		Korea, Republic of