NCT01797978

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
354

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2013

Typical duration for phase_3

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

November 18, 2015

Status Verified

November 1, 2015

Enrollment Period

2.9 years

First QC Date

February 21, 2013

Last Update Submit

November 16, 2015

Conditions

Severe SepsisSeptic Shock

Keywords

SepsisSeptic shockMethylene blue

Outcome Measures

Primary Outcomes (1)

  • 28 day mortality

    within 28 days of diagnosis

Secondary Outcomes (9)

  • 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)

    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

  • +4 more secondary outcomes

Study Arms (2)

Intravenous methylene blue administration

EXPERIMENTAL

2mg/kg IV bolus followed by 0.5mg/kg/hr slow infusion for 6hrs

Drug: Intravenous methylene blue administration

Placebo

PLACEBO COMPARATOR

Normal saline administration instead of methylene blue

Drug: Placebo

Interventions

Intravenous methylene blue administrationDRUG

Initial history taking and physical examination --\> enrollment --\> 2mg/kg IV bolus followed by 0.5mg/kg/hr slow infusion of methylene blue for 6hrs

Also known as: methylene blue administration, MB administration
Intravenous methylene blue administration
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Septic shock meeting the criteria of 2012 surviving sepsis campaign
  • Need the norepinephrine of over 0.2microgram/kg/min

You may not qualify if:

  • Pregnancy
  • Less than 18 years old
  • Terminal cancer patients
  • Declined consents
  • glucose-6-phosphate dehydrogenase deficiency
  • Medication of Serotonin modulator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Seoul National University Bundang Hospital

Seongnam-si, Kyeongi-do, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

SMG - SNU Boramae Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

SepsisShock, Septic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Kyuseok Kim, MD

    Professor, department of emergency medicine

    STUDY DIRECTOR

Central Study Contacts

Kyuseok Kim, MD

CONTACT

+82-31-787-7572dremkks@snubh.org

Chanjong Park, MD

CONTACT

+82-10-3902-3291mickeyp@snubh.org

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2013

First Posted

February 25, 2013

Study Start

February 1, 2013

Primary Completion

January 1, 2016

Study Completion

March 1, 2017

Last Updated

November 18, 2015

Record last verified: 2015-11

Locations

KR(3)