Early Methylene Blue in the Microhemodynamics of Septic Patients

What Was Tested

This registered phase 2, phase 3 trial tested Methylene blue (non-peptide stack partner).

It had two arms (groups): Methylene blue group (experimental) and Control group (no intervention).

The intervention group will receive methylene blue plus standard treatment for septic shock, according to the international guidelines.

The control group will receive the standard treatment according to international guidelines for the management of sepsis and septic shock.

The registry classes the interventions as drug.

More on the Plan

One of the primary causes of high mortality in patients with septic shock is microcirculatory dysfunction related to vasodilation caused by excessive oxide nitric production.

For this purpose, a pilot study of an open-label, randomized, controlled and single-center clinical trial will be conducted, with two treatment arms: the intervention group (methylene blue plus standard treatment) and the control group (standard treatment).

Fifty adult patients with septic shock within the first six hours of diagnosis will be included in this study.

They will be randomized to either receive a methylene blue infusion or not.

Who Took Part

The registry lists 50 planned participants were the target.

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.

The full record lists 1 inclusion and 9 exclusion criteria; among the exclusions: pregnant or breastfeeding patients;; patients with any withdrawal or withholding life-sustaining intervention;; cardiac surgery patients in the immediate postoperative period;.

How the Study Was Run

Design: 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.

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 2026-01-09 with completion listed for 2026-11-30.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: To evaluate the feasibility of the study protocol (time frame: 28 days after randomization).

It also tracked 10 secondary outcomes, for example Capillary refill time, Serum lactate level, Arteriovenous carbon dioxide difference (gapCO2), Central venous oxygen saturation (SvO2), Serial measurements of heart rate and Serial measurements of mean arterial pressure.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Methylene blue (non-peptide stack partner) in 50 people.

It is still recruiting; 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.