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Methylene Blue in Severe Sepsis and Septic Shock

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01797978
First received: February 21, 2013
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Severe Sepsis
Septic Shock
Drug: Intravenous methylene blue administration
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Infusion of Methylene Blue in Severe Sepsis and Septic Shock: Randomized, Single Blinded

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 28 day mortality [ Time Frame: within 28 days of diagnosis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vasopressor dependent period [ Time Frame: within 28 days of diagnosis ] [ Designated as safety issue: No ]
  • Vasopressor index [ Time Frame: with in 28 days of diagnosis ] [ Designated as safety issue: No ]
  • Change of cardiac output (CO) and systemic vascular resistance (SVR) [ Time Frame: with in 28 days of diagnosis ] [ Designated as safety issue: No ]
    EV1000 (Edwards inc.) will be used to see the cardiac output and systemic vascular resistance.

  • Length of stay in ICU (LOSICU) [ Time Frame: with in 28 days of diagnosis ] [ Designated as safety issue: No ]
  • LOS in hospital [ Time Frame: with in 28 days of diagnosis ] [ Designated as safety issue: No ]
  • In hospital mortality [ Time Frame: with in 28 days of diagnosis ] [ Designated as safety issue: No ]
  • Multiple organ failure (SOFA) [ Time Frame: with in 28 days of diagnosis ] [ Designated as safety issue: No ]
  • NO level [ Time Frame: before and after infusion of MB, 24hrs, 48hrs later ] [ Designated as safety issue: No ]
  • Cytokine level (IL-6, 10, tumor necrosis factor -alpha) [ Time Frame: before and after infusion of MB, 24hrs, 48hrs later ] [ Designated as safety issue: No ]

Estimated Enrollment: 354
Study Start Date: February 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01797978

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

Locations
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
Study Director: Kyuseok Kim, MD Professor, department of emergency medicine
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01797978     History of Changes
Other Study ID Numbers: B-1210/173-002
Study First Received: February 21, 2013
Last Updated: August 4, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
Sepsis
Septic shock
Methylene blue

Additional relevant MeSH terms:
Shock
Shock, Septic
Sepsis
Toxemia
Infection
Inflammation
Pathologic Processes
Systemic Inflammatory Response Syndrome
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2014