Methylene Blue as a Third-line Vasopressor in Septic Shock

What Was Tested

In this phase 2 trial, researchers set out to test Methylene blue (non-peptide stack partner).

A randomized, prospective study comparing ProvayBlue® to standard care with multiple sympathomimetic vasopressors.

It had two arms (groups): Control group (experimental) and Intervention group (experimental).

The registry classes the interventions as drug.

More on the Plan

The study will be an un-blinded, Phase 2, randomized, 1:1, prospective trial comparing patients in septic shock receiving norepinephrine and vasopressin followed by phenylephrine versus ProvayBlue® as the third-line vasopressor.

The third line vasopressor will be compared at 1 hour to see if it affects the patient's mean arterial blood pressure (MAP).

Who Took Part

250 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 0 inclusion and 11 exclusion criteria; among the exclusions: children less than 18 years old; pregnant women or positive urinary pregnancy test in reproductive-aged women; known grade 3 diastolic dysfunction document by echocardiogram.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

Everyone knew when Methylene blue (non-peptide stack partner) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2019-12-01 with completion listed for 2024-10-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in mean arterial pressure.

It also tracked 1 secondary outcome, for example Incidence of acute kidney injury requiring dialysis.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Methylene blue (non-peptide stack partner) in 250 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.