Methylene Blue in Severe Sepsis and Septic Shock

Septic Shock Clinical Trial

Official title:

Infusion of Methylene Blue in Severe Sepsis and Septic Shock: Randomized, Single Blinded

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01797978
• Other study ID #: B-1210/173-002
• Status: Recruiting
• Phase: Phase 3
• First received: February 21, 2013
• Last updated: November 16, 2015
• Start date: February 2013
• Est. completion date: March 2017

Study information

• Verified date: November 2015
• Source: Seoul National University Hospital
• Contact: Kyuseok Kim, MD
• Phone: +82-31-787-7572
• Email: dremkks[@]snubh.org
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is to see whether the intravenous administration of methylene blue improves the outcome in severe sepsis and septic shock.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 354
• Est. completion date: March 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Severe Sepsis
• Shock
• Shock, Septic
• Toxemia

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
• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Kyeongi-do
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	SMG - SNU Boramae Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28 day mortality		within 28 days of diagnosis	No
Secondary	Vasopressor dependent period		within 28 days of diagnosis	No
Secondary	Vasopressor index		with in 28 days of diagnosis	No
Secondary	Change of cardiac output (CO) and systemic vascular resistance (SVR)	EV1000 (Edwards inc.) will be used to see the cardiac output and systemic vascular resistance.	with in 28 days of diagnosis	No
Secondary	Length of stay in ICU (LOSICU)		with in 28 days of diagnosis	No
Secondary	LOS in hospital		with in 28 days of diagnosis	No
Secondary	In hospital mortality		with in 28 days of diagnosis	No
Secondary	Multiple organ failure (SOFA)		with in 28 days of diagnosis	No
Secondary	NO level		before and after infusion of MB, 24hrs, 48hrs later	No
Secondary	Cytokine level (IL-6, 10, tumor necrosis factor -alpha)		before and after infusion of MB, 24hrs, 48hrs later	No