Septic Shock, Severe Sepsis
Conditions
Keywords
Sepsis, Septic shock, Methylene blue
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.
Interventions
DRUGIntravenous 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
DRUGPlacebo
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28 day mortality | within 28 days of diagnosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vasopressor index | with in 28 days of diagnosis | — |
| Change of cardiac output (CO) and systemic vascular resistance (SVR) | 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) | with in 28 days of diagnosis | — |
| LOS in hospital | with in 28 days of diagnosis | — |
| Vasopressor dependent period | within 28 days of diagnosis | — |
| Multiple organ failure (SOFA) | with in 28 days of diagnosis | — |
| NO level | before and after infusion of MB, 24hrs, 48hrs later | — |
| Cytokine level (IL-6, 10, tumor necrosis factor -alpha) | before and after infusion of MB, 24hrs, 48hrs later | — |
| In hospital mortality | with in 28 days of diagnosis | — |
Countries
South Korea
Contacts
Primary ContactKyuseok Kim, MD
Backup ContactChanjong Park, MD
Outcome results
None listed