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This study is to see whether the intravenous administration of methylene blue improves the outcome in severe sepsis and septic shock.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous methylene blue administration | Experimental | 2mg/kg IV bolus followed by 0.5mg/kg/hr slow infusion for 6hrs |
|
| Placebo | Placebo Comparator | Normal saline administration instead of methylene blue |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous methylene blue administration | Drug | Initial history taking and physical examination --> enrollment --> 2mg/kg IV bolus followed by 0.5mg/kg/hr slow infusion of methylene blue for 6hrs |
| Measure | Description | Time Frame |
|---|---|---|
| 28 day mortality | within 28 days of diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| Vasopressor dependent period | within 28 days of diagnosis | |
| Vasopressor index | with in 28 days of diagnosis | |
| Change of cardiac output (CO) and systemic vascular resistance (SVR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kyuseok Kim, MD | Contact | +82-31-787-7572 | dremkks@snubh.org | |
| Chanjong Park, MD | Contact | +82-10-3902-3291 | mickeyp@snubh.org |
| Name | Affiliation | Role |
|---|---|---|
| Kyuseok Kim, MD | Professor, department of emergency medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Kyeongi-do | South Korea |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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|
| Placebo | Drug |
|
EV1000 (Edwards inc.) will be used to see the cardiac output and systemic vascular resistance. |
| with in 28 days of diagnosis |
| Length of stay in ICU (LOSICU) | with in 28 days of diagnosis |
| LOS in hospital | with in 28 days of diagnosis |
| In hospital mortality | with in 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 |
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
|
| SMG - SNU Boramae Medical Center | Recruiting | Seoul | South Korea |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |