Efficacy and Safety of Methylene Blue in the Treatment of Severe Septic Shock

What Was Tested

In this not phased trial, researchers set out to test Methylene blue (non-peptide stack partner).

It had two arms (groups): one (experimental) and one (placebo comparator).

Normal saline solution, administered in the same manner and duration as the methylene blue intervention.

The registry classes the interventions as drug.

More on the Plan

Researchers will compare methylene blue to a placebo (a look-alike substance that contains no drug) to see if methylene blue works to treat severe septic shock.

Primary Study Endpoint \- 28-day all-cause mortality rate starting from the diagnosis of septic shock.

Who Took Part

Enrollment: 488 planned participants were the target.

It was open to people of any sex.

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

Examples of who could join: Age ≥ 18 years. Diagnosed with septic shock and started on norepinephrine within 24 hours.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: pregnant or breastfeeding women; individuals allergic to methylene blue or any components of the methylene blue injection; individuals with a personal or family history of glucose-6-phosphate dehydrogenase (g6pd) deficiency.

How the Study Was Run

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

The participants were allocated by chance, so the Methylene blue (non-peptide stack partner) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2024-06-22 with completion listed for 2026-06-20.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 28-day survival rate of enrolled patients (time frame: 28-day).

It also tracked 5 secondary outcomes, for example The duration of mechanical ventilation, The duration of ICU stay and The safety of methylene blue injection.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Methylene blue (non-peptide stack partner) in 488 people.

Its status is unknown; 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.