Blue dye tested in septic shock: could it help ICU patients?
NCT ID NCT06900140
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tested whether adding methylene blue to standard care is feasible for adults with septic shock in the intensive care unit. The main goal was to see if a larger trial could be done, not to prove the treatment works. Fifty patients took part, and the study looked at how many could be enrolled and how well they followed the treatment plan.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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50 people
The number who actually took part.
- Started
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Jun 2025
- Finished
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Mar 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Lakeridge Health Ajax-Pickering
Ajax, Ontario, Canada
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Lakeridge Health Oshawa
Oshawa, Ontario, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a blood filter strip away toxins in septic shock?
- Which ultrasound tool spots fluid overload sooner in septic shock?
- Can a drug rev up the immune system to fight sepsis?
- Can an antidepressant stabilize blood pressure in septic shock?
- Can a simple leg raise guide sepsis fluid treatment?
- A new blood marker may outperform lactate in predicting septic shock survival