Methylene Blue in Severe Sepsis and Septic Shock

• ClinicalTrials.gov Identifier: NCT01797978
• Recruitment Status: Unknown
• First Posted: February 25, 2013
• Last Update Posted: November 18, 2015
• Sponsor: Seoul National University Hospital
• Information provided by (Responsible Party): Seoul National University Hospital

Tracking Information

• First Submitted Date: February 21, 2013
• First Posted Date: February 25, 2013
• Last Update Posted Date: November 18, 2015
• Study Start Date: February 2013
• Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 22, 2013): 28 day mortality [ Time Frame: within 28 days of diagnosis ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 22, 2013)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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 Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment

Condition

• Severe Sepsis
• Septic Shock

Intervention

• 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
• Drug: Placebo

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: November 5, 2013): 354
• Original Estimated Enrollment (submitted: February 22, 2013): 348
• Estimated Study Completion Date: March 2017
• Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT01797978
• Other Study ID Numbers: B-1210/173-002
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Seoul National University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Seoul National University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Kyuseok Kim, MD; Professor, department of emergency medicine

• PRS Account: Seoul National University Hospital
• Verification Date: November 2015