Methylene Blue in Severe Sepsis and Septic Shock

What Was Tested

In this phase 3 trial, researchers set out to test Methylene blue (non-peptide stack partner).

It had two arms (groups): Intravenous methylene blue administration (experimental) and Placebo (placebo comparator).

Normal saline administration instead of methylene blue.

The registry classes the interventions as drug.

More on the Plan

Vasopressor is the main part in managing septic shock, but the choice of vasopressor is still under-investigated, and area of uncertainty.

The response to vasopressor is sometimes unsatisfactory, and in that case, the outcome of the patients is poor.

However, large sized phase III trial has not been performed yet.

Large sized phase III clinical trial is needed to establish the effect of MB in septic shock.

Who Took Part

Enrollment: 354 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.

Examples of who could join: Septic shock meeting the criteria of 2012 surviving sepsis campaign.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: less than 18 years old; terminal cancer patients; declined consents.

How the Study Was Run

Design: randomized, parallel-group and single-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.

In this single-blind Methylene blue (non-peptide stack partner) study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2013-02 with completion listed for 2016-01.

It ran at 3 sites in South Korea (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 28 day mortality (time frame: within 28 days of diagnosis).

It also tracked 9 secondary outcomes, for example Vasopressor dependent period, Vasopressor index, Change of cardiac output (CO) and systemic vascular resistance (SVR), Length of stay in ICU (LOSICU), Multiple organ failure (SOFA) and NO level.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Methylene blue (non-peptide stack partner) in 354 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.