CompletedPhase 3

Adjunctive Methylene Blue in Septic Shock

Canada50 participantsStarted 2025-06-02

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. \> 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

What they're measuring

Enrolment/Recruitment Rate

Timeframe: Enrolment

Consent Rate

Timeframe: Enrolment

Protocol Adherence

Timeframe: Enrolment

Trial details

NCT IDNCT06900140

SponsorDr. Shannon M. Fernando

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-06

View on ClinicalTrials.gov More Septic Shock trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. \> 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