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Methylene Blue for the Treatment of Septic Shock

Plain-language guide to NCT06532240: phase 3 randomized trial of Methylene blue (non-peptide stack partner), 88 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06532240
Phase
phase 3
Status
completed
Start
2024-08-05
Completion (planned or actual)
2025-10-24
Participants
88 (actual)
Design
randomized, quadruple-blind, treatment
Conditions studied
Septic Shock
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 3) is built around Methylene blue (non-peptide stack partner).

It had two arms (groups): Methylene Blue (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Septic Shock is a leading cause of morbidity and mortality in critically ill patients worldwide.

Who Took Part

The registry lists 88 actual participants took part.

It was open to people of any sex aged from 18 years up to 90 years.

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

Examples of who could join: Age 18 years old or older;. Diagnosis of septic shock within 12 h.

The full record lists 2 inclusion and 8 exclusion criteria; among the exclusions: recent intake (4-weeks) of selective serotonin re-uptake inhibitors;; definitive pulmonary hypertension or chronic pulmonary heart disease;; known glucose-6 phosphate dehydrogenase (g-6pd) deficiency;.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Methylene blue (non-peptide stack partner) and who got the comparison, which limits bias.

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

As a double-blind Methylene blue (non-peptide stack partner) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-08-05 with completion listed for 2025-10-24.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Time to shock reversal (time frame: 90 days after randomization).

It also tracked 4 secondary outcomes, for example 28-day mortality, 90-day mortality and ICU mortality.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Methylene blue (non-peptide stack partner) in 88 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.

Our Notes on the Compound

Methylene blue (non-peptide stack partner): Described as an electron cycler, not just a dye.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.