Infusion of Methylene Blue in Severe Sepsis and Septic Shock: Randomized, Double
18 Years
N/A
Both
Severe Sepsis, Septic Shock
Trial Information
Infusion of Methylene Blue in Severe Sepsis and Septic Shock: Randomized, Double
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.
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
- Immunosuppressant patients (e.g. on steroid medication, active anti-cancer
chemotherapeutic agent, etc.)
- Declined consents
- glucose-6-phosphate dehydrogenase deficiency
- Medication of Serotonin modulator
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
28 day mortality
Outcome Time Frame:
within 28 days of diagnosis
Safety Issue:
No
Principal Investigator
Kyuseok Kim, MD
Investigator Role:
Study Director
Investigator Affiliation:
Professor, department of emergency medicine
Authority:
Korea: Food and Drug Administration
Study ID:
B-1210/173-002
NCT ID:
NCT01797978
Start Date:
February 2013
Completion Date:
March 2016
Related Keywords:
- Severe Sepsis
- Septic Shock
- Sepsis
- Septic shock
- Methylene blue
- Sepsis
- Toxemia
- Shock
- Shock, Septic
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