Methylene Blue for Septic Shock
(BLUSH Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether methylene blue, a medication, can aid adults in the ICU with septic shock, a severe infection that causes dangerously low blood pressure. Participants will receive either methylene blue infusions or continue with standard care to determine which method improves patient outcomes. Those diagnosed with septic shock and receiving specific blood pressure support treatments might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial requires that you stop taking selective serotonin re-uptake inhibitors (SSRIs) at least 14 days before joining, and norfluoxetine 21 days before. You also cannot participate if you are currently taking linezolid.
Is there any evidence suggesting that methylene blue is likely to be safe for humans?
Research has shown that methylene blue might be safe for people with septic shock. One study found it could reduce the time patients need medication to support blood pressure. Other studies suggest methylene blue might improve survival rates and shorten hospital stays for critically ill patients. However, some sources indicate that while the results are promising, more definitive evidence is needed to fully support its use. Overall, methylene blue appears well-tolerated, but it is important to consider all available information and consult a healthcare provider before deciding to join a trial.12345
Why do researchers think this study treatment might be promising for septic shock?
Methylene Blue is unique because it offers a new approach to treating septic shock by targeting nitric oxide pathways, which are involved in the widening of blood vessels during septic shock. Unlike the standard treatments that primarily focus on stabilizing blood pressure with fluids and vasopressors, Methylene Blue acts as a vasoconstrictor, potentially offering faster stabilization of blood pressure. Researchers are excited about its potential to improve outcomes in septic shock patients by addressing the underlying cause of low blood pressure more directly.
What evidence suggests that methylene blue might be an effective treatment for septic shock?
Research suggests that methylene blue, which participants in this trial may receive, might help people with septic shock. It has raised blood pressure and reduced the need for other heart-supporting medications. Some studies found that it can also shorten the time patients spend in the intensive care unit (ICU) and on breathing machines. However, the evidence is not entirely consistent, and some experts believe more research is needed to confirm these benefits. Methylene blue improves blood flow and helps the body respond to severe infections.46789
Who Is on the Research Team?
Shannon M Fernando, MD
Principal Investigator
Lakeridge Health
Are You a Good Fit for This Trial?
This trial is for adult patients in the intensive care unit diagnosed with septic shock. Specific eligibility criteria are not provided, but typically participants must meet certain health conditions and agree to follow study procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive methylene blue infusion or usual care for septic shock
Follow-up
Participants are monitored for organ function and vasopressor exposure
What Are the Treatments Tested in This Trial?
Interventions
- Methylene Blue
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dr. Shannon M. Fernando
Lead Sponsor