Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
354 participants
INTERVENTIONAL
2013-02-28
2017-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intravenous methylene blue administration
2mg/kg IV bolus followed by 0.5mg/kg/hr slow infusion for 6hrs
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
Placebo
Normal saline administration instead of methylene blue
Placebo
Interventions
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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
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Need the norepinephrine of over 0.2microgram/kg/min
Exclusion Criteria
* Less than 18 years old
* Terminal cancer patients
* Declined consents
* glucose-6-phosphate dehydrogenase deficiency
* Medication of Serotonin modulator
18 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Principal Investigators
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Kyuseok Kim, MD
Role: STUDY_DIRECTOR
Professor, department of emergency medicine
Locations
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Seoul National University Bundang Hospital
Seongnam-si, Kyeongi-do, South Korea
Seoul National University Hospital
Seoul, , South Korea
SMG - SNU Boramae Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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B-1210/173-002
Identifier Type: -
Identifier Source: org_study_id