Low Dose Versus High Dose Methylene Blue in Septic Patients

What Was Tested

The trial (phase 2, phase 3) is built around Methylene blue (non-peptide stack partner).

It had three arms (groups): Normal saline (active comparator), one (active comparator) and one (active comparator).

The registry classes the interventions as drug.

More on the Plan

Exaggerated host response to infection, may result in sepsis, which is life-threatening organ dysfunction .

The triad of intravenous fluid, vasopressors and antibiotics in the first hour is the mainstay of septic shock management.

Aim of management is to maintain patient hemodynamically stable until antibiotics kick in and fight infection.

Methylene blue (MB) is a nitric oxide inhibitor that can counteract the vasodilatation in early septic shock.

Who Took Part

Enrollment: 90 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

The full record lists 1 inclusion and 9 exclusion criteria; among the exclusions: myocardial infarction or cerebrovascular accident within the last 3 months; glucose 6-phosphate-dehydrogenase deficiency; known allergy to mb or food dyes and the use of nitrates within the last 3 days.

How the Study Was Run

The set-up was randomized, parallel-group and double-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.

Neither the participants nor the staff measuring them knew who was on Methylene blue (non-peptide stack partner), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and care provider.

It started in 2023-08-01 with completion listed for 2024-04-29.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Discontinuation of vasopressor (time frame: 7 days).

It also tracked 1 secondary outcome, for example Mortality.

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 90 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.