Status:
RECRUITING
Adjunctive Methylene Blue in Septic Shock
Lead Sponsor:
Dr. Shannon M. Fernando
Conditions:
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
BACKGROUND: Septic shock remains an important cause of morbidity and mortality worldwide, and disproportionately affects low- and middle-income countries. The current standard of care in the treatment...
Eligibility Criteria
Inclusion
- Adult patients (≥ 18 years of age) admitted to the ICU
- 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).
- 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
- \> 48 hours since initiation of norepinephrine
- \> 48 hours since admission to ICU
- Anticipation of discontinuation of vasopressors in \< 24 hours
- Pregnancy \*\*Women of childbearing age (\<50 years) should have a urine or beta hCG performed prior to enrolment
- Plan for withdrawal of life support
- Concurrent hemorrhagic, obstructive, or hypovolemic shock
- Major burn injury (\>10% total body surface area)
- Known Personal or familial history of glucose-6-phophate dehydrogenase deficiency
- Known Allergy to methylene blue, phenothiazines, or food dyes
- Known recent intake of selective serotonin re-uptake inhibitors (21 days for norfluoxetine, and 14 days for any other SSRI).
- Currently receiving linezolid
Key Trial Info
Start Date :
June 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06900140
Start Date
June 2 2025
End Date
October 31 2025
Last Update
June 6 2025
Active Locations (1)
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1
Lakeridge Health
Oshawa, Ontario, Canada