Adjunctive Methylene Blue in Septic Shock

Short name BLUSH

NCTNCT06900140Other idLHICU123

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 50 participants (actual)
Sponsor: Dr. Shannon M. Fernando · Other
Design: Randomized · Single masking
Countries: 1 country
Canada
Start: 2 Jun 2025
Primary completion: 6 Mar 2026
Completion: 6 Mar 2026
First posted: 28 Mar 2025
Last update posted: 19 Mar 2026
Conditions: Septic Shock

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202520262027

Ph 3
BLUSH
NCT06900140
2 Jun 2025 to 6 Mar 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Adjunctive Methylene BLUe in Septic SHock (BLUSH) is a single centre concealed-allocation parallel-group open-label randomized controlled pilot trial to ascertain the feasibility of a trial evaluating the efficacy and safety of adjunctive methylene blue infusion compared to usual care on outcomes of adult patients admitted to the intensive care unit with septic shock.

Interventions

Methylene BlueDrug
Usual CareOther

Arms2

Experimental
Methylene Blue
Methylene Blue infusion: 0.5 mg/kg/hr for 6 hours daily (up to 3 days total).
Active comparator
Usual Care
Usual guideline-directed care for adult septic shock.

Primary outcomes3

Outcomes the sponsor listed as primary.

Enrolment/Recruitment Rate
Time frame · Enrolment
Registry description
The investigators define a successful recruitment rate of 1 patient per centre per month over the duration of the trial. The recruitment will be reviewed weekly and the screening logs will be reviewed monthly. This will be done to ensure that enrolment is being maximized and that any barriers are being addressed. A recruitment metric will be measured and interpreted at the end of the trial. Excluded patients and eligible non-randomized patients will be reviewed to determine whether any modifications to the protocol may be warranted, or to address implementation challenges. Barriers to enrolment will be discussed and strategies to improve enrolment will be operationalized, if needed.
Consent Rate
Time frame · Enrolment
Registry description
The investigators will define \>50% consent rate as successful. This will be calculated as the overall proportion of patients/substitute decisions makers (SDMs) who consented to the trial out of everyone who was approached. If a patient or SDM chooses to withdraw from the study but allows for the data that had been collected up until that point to be used for analysis, they will still be counted as providing consent. Reasons for withdrawal will be recorded. The consent rate will be reviewed weekly and any barriers to consent that are identified will be addressed to improve the consent process.
Protocol Adherence
Time frame · Enrolment
Registry description
The investigators will define ≥80% protocol adherence as successful. The adherence will be calculated as the number of patients who received allocated therapy per eligible study day over all the eligible study intervention days across enrolled patients. Each enrolled patient will contribute 3 eligible study intervention days unless they meet discontinuation criteria (e.g., stopped vasopressors). The research coordinator will review the chart to determine the actual compliance, and document all the reasons for non-compliance of both the control and experimental arms of the study. Furthermore, the study drug being discontinued and then re-started in a study patient would also not be deemed a protocol violation. Adherence will also be reviewed monthly and the reasons for compliance failure will be investigated and recorded as a protocol violation. Further behavioural strategies will be employed to improve adherence, if needed.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Adult patients (≥ 18 years of age) admitted to the ICU 2. Diagnosed with septic shock (as per the Sepsis-3 Criteria): Suspected infection (i.e. initiation of antimicrobial therapy), coupled with initiation of vasopressor therapy to target a mean arterial pressure (MAP) \> 65 mmHg (or as prescribed by the treating clinician), after adequate fluid resuscitation (as per treating clinician). 3. Minimal norepinephrine dose of 0.1 mcg/kg/min for a minimum of 2 hours at the time of enrollment (i.e., the time of randomization). Exclusion Criteria: 1. \> 48 hours since initiation of norepinephrine 2. \> 48 hours since admission to ICU 3. Anticipation of discontinuation of vasopressors in \< 24 hours 4. Pregnancy \*\*Women of childbearing age (\<50 years) should have a urine or beta hCG performed prior to enrolment 5. Plan for withdrawal of life support 6. Concurrent hemorrhagic, obstructive, or hypovolemic shock 7. Major burn injury (\>10% total body surface area) 8. Known Personal or familial history of glucose-6-phophate dehydrogenase deficiency 9. Known Allergy to methylene blue, phenothiazines, or food dyes 10. Known recent intake of selective serotonin re-uptake inhibitors (21 days for norfluoxetine, and 14 days for any other SSRI). 11. Currently receiving linezolid

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