Adjunctive Methylene Blue in Septic Shock

What Was Tested

In this phase 3 trial, researchers set out to test Methylene blue (non-peptide stack partner).

It had two arms (groups): Methylene Blue (experimental) and Usual Care (active comparator).

Usual guideline-directed care for adult septic shock.

The registry classes the interventions as drug and other.

More on the Plan

BACKGROUND: Septic shock remains an important cause of morbidity and mortality worldwide, and disproportionately affects low- and middle-income countries.

The current standard of care in the treatment of septic shock is limited to antimicrobials and supportive care such as intravenous fluids, vasopressors, mechanical ventilation, and renal replacement therapy.

Daily assessments will occur for organ function and vasopressor exposure.

The trial will be conducted in two adult intensive care units at Lakeridge Health.

Who Took Part

Enrollment: 50 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adult patients (≥ 18 years of age) admitted to the ICU.

The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: \> 48 hours since initiation of norepinephrine; \> 48 hours since admission to icu; anticipation of discontinuation of vasopressors in \< 24 hours.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

Because people in this Methylene blue (non-peptide stack partner) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Methylene blue (non-peptide stack partner) group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether Methylene blue (non-peptide stack partner) was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2025-06-02 with completion listed for 2026-03-06.

It ran at 2 sites in Canada (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Enrolment/Recruitment Rate (time frame: Enrolment). Consent Rate (time frame: Enrolment). Protocol Adherence (time frame: Enrolment).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Methylene blue (non-peptide stack partner) in 50 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.