Adjunctive Methylene Blue in Septic Shock

Launched by DR. SHANNON M. FERNANDO · Mar 26, 2025

Keywords

ClinConnect Summary

This clinical trial, called BLUSH, is exploring a treatment called methylene blue for patients suffering from septic shock, a serious condition that occurs when an infection leads to dangerously low blood pressure. The study aims to see if adding methylene blue to the usual care provided in the intensive care unit (ICU) can improve patient outcomes. The trial is currently not recruiting participants but will focus on adult patients aged 18 and older who are diagnosed with septic shock and are receiving specific treatments, including a medication called norepinephrine to help raise their blood pressure.

To be eligible for this trial, patients must be in the ICU, have started treatment for an infection, and be on a certain dose of norepinephrine for at least two hours. However, there are some exclusions, such as having been in the ICU for more than 48 hours or having specific medical conditions. Participants can expect to receive either the methylene blue treatment or the standard care, and the trial will help researchers understand if methylene blue is safe and effective for improving the health of patients with this serious condition.

Gender

ALL

Eligibility criteria

• 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