Adjunctive Methylene BLUe in Septic SHock: a Pilot Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Canada
Lakeridge Health
RECRUITING
Oshawa
Contact Information
Primary
Shannon M Fernando, MD
sfernando@lh.ca
905-576-8711
Time Frame
Start Date: 2025-06-02
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 30
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Dr. Shannon M. Fernando

This content was sourced from clinicaltrials.gov