Severe SepsisPhase 3NCT01797978
Methylene Blue in Severe Sepsis and Septic Shock
A Phase 3 study testing Intravenous methylene blue administration in people with Severe Sepsis and Septic Shock, run by Seoul National University Hospital at 3 sites in South Korea.
Trial summary
This study is to see whether the intravenous administration of methylene blue improves the outcome in severe sepsis and septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis, Septic Shock
- What is being tested?
- Intravenous methylene blue administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 354 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Feb 2013to Mar 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Septic shock meeting the criteria of 2012 surviving sepsis campaign
- Need the norepinephrine of over 0.2microgram/kg/min
Who cannot join
- Pregnancy
- Less than 18 years old
- Terminal cancer patients
- Declined consents
- glucose-6-phosphate dehydrogenase deficiency
- Medication of Serotonin modulator
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites, 3 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Kyeongi-do
Kyuseok Kim, MD, +82-31-787-7572, dremkks@snubh.org
- Recruiting
Seoul National University Hospital
Seoul
Kyuseok Kim, +82-31-787-7572, dremkks@snubh.org
- Recruiting
SMG - SNU Boramae Medical Center
Seoul
Kyuseok Kim, +82-31-787-7572, dremkks@snubh.org
About this study
Official title: Infusion of Methylene Blue in Severe Sepsis and Septic Shock: Randomized, Single Blinded
This study is to see whether the intravenous administration of methylene blue improves the outcome in severe sepsis and septic shock.
Read the 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.
- Conditions
- Severe Sepsis, Septic Shock
- Being tested
- Intravenous methylene blue administration, Placebo
- Keywords
- Sepsis, Septic shock, Methylene blue
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous methylene blue administrationDrug
Also called methylene blue administration, MB 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
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Intravenous methylene blue administration | Experimental | 2mg/kg IV bolus followed by 0.5mg/kg/hr slow infusion for 6hrs Receives: Drug: Intravenous methylene blue administration |
| Placebo | Placebo comparator | Normal saline administration instead of methylene blue Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
28 day mortality
Measured: within 28 days of diagnosis
Secondary outcomes (9)
Vasopressor dependent period
Measured: within 28 days of diagnosis
Vasopressor index
Measured: with in 28 days of diagnosis
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.
Measured: with in 28 days of diagnosis
Length of stay in ICU (LOSICU)
Measured: with in 28 days of diagnosis
LOS in hospital
Measured: with in 28 days of diagnosis
In hospital mortality
Measured: with in 28 days of diagnosis
Multiple organ failure (SOFA)
Measured: with in 28 days of diagnosis
NO level
Measured: before and after infusion of MB, 24hrs, 48hrs later
Cytokine level (IL-6, 10, tumor necrosis factor -alpha)
Measured: before and after infusion of MB, 24hrs, 48hrs later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionJan 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 354 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyuseok Kim, MD, Study director, Professor, department of emergency medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797978
- Sponsor's protocol ID
- B-1210/173-002
- Status last verified
- Nov 2015
- First submitted
- 21 Feb 2013
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infusion of Methylene Blue in Severe Sepsis and Septic Shock: Randomized, Single Blinded
- ClinicalTrials.gov ID
- NCT01797978
- Acronym / sponsor ID
- B-1210/173-002
- Conditions
- Severe Sepsis, Septic Shock
- Keywords
- Sepsis, Septic shock, Methylene blue
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 354 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 25 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous methylene blue administration | Experimental | Drug: Intravenous methylene blue administration2mg/kg IV bolus followed by 0.5mg/kg/hr slow infusion for 6hrs |
| Placebo | Placebo comparator | Drug: PlaceboNormal saline administration instead of methylene blue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Septic shock meeting the criteria of 2012 surviving sepsis campaign
- Need the norepinephrine of over 0.2microgram/kg/min
Key exclusion criteria (6 listed)
- Pregnancy
- Less than 18 years old
- Terminal cancer patients
- Declined consents
- glucose-6-phosphate dehydrogenase deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous methylene blue administrationAlso: methylene blue administration, MB administrationInitial history taking and physical examination --> enrollment --> 2mg/kg IV bolus followed by 0.5mg/kg/hr slow infusion of methylene blue for 6hrs | Drug | Intravenous methylene blue administration |
| Placebo | Drug | Placebo |
Primary outcome
28 day mortality
Time frame: within 28 days of diagnosis
9 secondary outcomes
Vasopressor dependent period
Time frame: within 28 days of diagnosis
Vasopressor index
Time frame: with in 28 days of diagnosis
Change of cardiac output (CO) and systemic vascular resistance (SVR)
Time frame: with in 28 days of diagnosis
Length of stay in ICU (LOSICU)
Time frame: with in 28 days of diagnosis
LOS in hospital
Time frame: with in 28 days of diagnosis
In hospital mortality
Time frame: with in 28 days of diagnosis
Multiple organ failure (SOFA)
Time frame: with in 28 days of diagnosis
NO level
Time frame: before and after infusion of MB, 24hrs, 48hrs later
Cytokine level (IL-6, 10, tumor necrosis factor -alpha)
Time frame: before and after infusion of MB, 24hrs, 48hrs later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyuseok Kim, MD study director
Professor, department of emergency medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravenous methylene blue administration in people with Severe Sepsis and Septic Shock, run by Seoul National University Hospital at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyuseok Kim, MD (+82-31-787-7572, dremkks@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28 day mortality (time frame: within 28 days of diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2015.