Methylene Blue in Early Septic Shock

What Was Tested

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

It had two arms (groups): Standard care (placebo comparator) and Methylene blue (experimental).

Placebo.

Methylene blue.

The registry classes the interventions as drug.

More on the Plan

Methylene blue (MB) is a selective inhibitor of iNOS, which has been used successfully in patients with post-cardiopulmonary bypass associated vasoplegia, however, the evidence of the use of MB in septic shock patients is limited to case reports, observational and small studies.

Who Took Part

91 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Septic shock diagnosis, according to the Sepsis-3 consensus. Prior adequate fluid resuscitation according to dynamic predictors of volume responsiveness. More than 6 h and less than 24 h of norepinephrine requirement to maintain a mean arterial pressure ≥65 mmHg.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: age \< 18 years; not expected to survive 48 hours; presence or high suspicion of concurrent hemorrhagic, obstructive or hypovolemic shock.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Because people in this Methylene blue (non-peptide stack partner) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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, care provider, investigator and outcomes assessor.

It started in 2017-03-17 with completion listed for 2020-12-10.

It ran at 1 site in Mexico.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Vasopressor requirement (time frame: 28 days).

It also tracked 3 secondary outcomes, for example Time to lactate normalization, Length of stay in intensive care unit and Intensive care unit 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 91 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.