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Methylene Blue in Severe Sepsis and Septic Shock

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01797978
Recruitment Status : Unknown
Verified November 2015 by Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : February 25, 2013
Last Update Posted : November 18, 2015
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 2013
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 28 day mortality [ Time Frame: within 28 days of diagnosis ]

Secondary Outcome Measures :
  1. Vasopressor dependent period [ Time Frame: within 28 days of diagnosis ]
  2. Vasopressor index [ Time Frame: with in 28 days of diagnosis ]
  3. Change of cardiac output (CO) and systemic vascular resistance (SVR) [ Time Frame: with in 28 days of diagnosis ]
    EV1000 (Edwards inc.) will be used to see the cardiac output and systemic vascular resistance.

  4. Length of stay in ICU (LOSICU) [ Time Frame: with in 28 days of diagnosis ]
  5. LOS in hospital [ Time Frame: with in 28 days of diagnosis ]
  6. In hospital mortality [ Time Frame: with in 28 days of diagnosis ]
  7. Multiple organ failure (SOFA) [ Time Frame: with in 28 days of diagnosis ]
  8. NO level [ Time Frame: before and after infusion of MB, 24hrs, 48hrs later ]
  9. Cytokine level (IL-6, 10, tumor necrosis factor -alpha) [ Time Frame: before and after infusion of MB, 24hrs, 48hrs later ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01797978


Contacts
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Contact: Kyuseok Kim, MD +82-31-787-7572 dremkks@snubh.org
Contact: Chanjong Park, MD +82-10-3902-3291 mickeyp@snubh.org

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Kyeongi-do, Korea, Republic of
Contact: Kyuseok Kim, MD    +82-31-787-7572    dremkks@snubh.org   
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Kyuseok Kim    +82-31-787-7572    dremkks@snubh.org   
SMG - SNU Boramae Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Kyuseok Kim    +82-31-787-7572    dremkks@snubh.org   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Director: Kyuseok Kim, MD Professor, department of emergency medicine
More Information
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01797978    
Other Study ID Numbers: B-1210/173-002
First Posted: February 25, 2013    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: November 2015
Keywords provided by Seoul National University Hospital:
Sepsis
Septic shock
Methylene blue
Additional relevant MeSH terms:
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Sepsis
Toxemia
Shock, Septic
Shock
Infections
Systemic Inflammatory Response Syndrome
 Inflammation
Pathologic Processes
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action