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Methylene Blue in Severe Sepsis and Septic Shock

Primary Purpose

Severe Sepsis, Septic Shock

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Intravenous methylene blue administration
Placebo
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Sepsis focused on measuring Sepsis, Septic shock, Methylene blue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • SMG - SNU Boramae Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intravenous methylene blue administration

Placebo

Arm Description

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

Normal saline administration instead of methylene blue

Outcomes

Primary Outcome Measures

28 day mortality

Secondary Outcome Measures

Vasopressor dependent period
Vasopressor index
Change of cardiac output (CO) and systemic vascular resistance (SVR)
EV1000 (Edwards inc.) will be used to see the cardiac output and systemic vascular resistance.
Length of stay in ICU (LOSICU)
LOS in hospital
In hospital mortality
Multiple organ failure (SOFA)
NO level
Cytokine level (IL-6, 10, tumor necrosis factor -alpha)

Full Information

First Posted
February 21, 2013
Last Updated
November 16, 2015
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01797978
Brief Title
Methylene Blue in Severe Sepsis and Septic Shock
Official Title
Infusion of Methylene Blue in Severe Sepsis and Septic Shock: Randomized, Single Blinded
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis, Septic Shock
Keywords
Sepsis, Septic shock, Methylene blue

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
354 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intravenous methylene blue administration
Arm Type
Experimental
Arm Description
2mg/kg IV bolus followed by 0.5mg/kg/hr slow infusion for 6hrs
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline administration instead of methylene blue
Intervention Type
Drug
Intervention Name(s)
Intravenous methylene blue administration
Other Intervention Name(s)
methylene blue administration, MB administration
Intervention Description
Initial history taking and physical examination --> enrollment --> 2mg/kg IV bolus followed by 0.5mg/kg/hr slow infusion of methylene blue for 6hrs
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
28 day mortality
Time Frame
within 28 days of diagnosis
Secondary Outcome Measure Information:
Title
Vasopressor dependent period
Time Frame
within 28 days of diagnosis
Title
Vasopressor index
Time Frame
with in 28 days of diagnosis
Title
Change of cardiac output (CO) and systemic vascular resistance (SVR)
Description
EV1000 (Edwards inc.) will be used to see the cardiac output and systemic vascular resistance.
Time Frame
with in 28 days of diagnosis
Title
Length of stay in ICU (LOSICU)
Time Frame
with in 28 days of diagnosis
Title
LOS in hospital
Time Frame
with in 28 days of diagnosis
Title
In hospital mortality
Time Frame
with in 28 days of diagnosis
Title
Multiple organ failure (SOFA)
Time Frame
with in 28 days of diagnosis
Title
NO level
Time Frame
before and after infusion of MB, 24hrs, 48hrs later
Title
Cytokine level (IL-6, 10, tumor necrosis factor -alpha)
Time Frame
before and after infusion of MB, 24hrs, 48hrs later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kyuseok Kim, MD
Phone
+82-31-787-7572
Email
dremkks@snubh.org
First Name & Middle Initial & Last Name or Official Title & Degree
Chanjong Park, MD
Phone
+82-10-3902-3291
Email
mickeyp@snubh.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyuseok Kim, MD
Organizational Affiliation
Professor, department of emergency medicine
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Kyeongi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyuseok Kim, MD
Phone
+82-31-787-7572
Email
dremkks@snubh.org
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyuseok Kim
Phone
+82-31-787-7572
Email
dremkks@snubh.org
Facility Name
SMG - SNU Boramae Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyuseok Kim
Phone
+82-31-787-7572
Email
dremkks@snubh.org

12. IPD Sharing Statement

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Methylene Blue in Severe Sepsis and Septic Shock

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