Methylene Blue in Severe Sepsis and Septic Shock

Last updated: November 16, 2015
Sponsor: Seoul National University Hospital
Overall Status: Trial Status Unknown

Phase

3

Condition

Soft Tissue Infections

Sepsis And Septicemia

Low Blood Pressure (Hypotension)

Treatment

N/A

Clinical Study ID

NCT01797978
B-1210/173-002
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Septic shock meeting the criteria of 2012 surviving sepsis campaign

  • Need the norepinephrine of over 0.2microgram/kg/min

Exclusion

Exclusion Criteria:

  • Pregnancy

  • Less than 18 years old

  • Terminal cancer patients

  • Declined consents

  • glucose-6-phosphate dehydrogenase deficiency

  • Medication of Serotonin modulator

Study Design

Total Participants: 354
Study Start date:
February 01, 2013
Estimated Completion Date:
March 31, 2017

Study 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.

Connect with a study center

  • Seoul National University Bundang Hospital

    Seongnam-si, Kyeongi-do
    Korea, Republic of

    Active - Recruiting

  • SMG - SNU Boramae Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

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