Methylene Blue and Microcirculation in Septic Shock

What Was Tested

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

This trial aims to identify the effects of methylene blue infusion on the the micro-circulation in patients with septic shock.

The investigators will evaluate various indices of micro-circulation such as: microvascular flow index, the flow heterogeneity index, the total vessel density, the perfused vessel density, and the proportion of perfused vessels.

It had two arms (groups): methylene blue group (experimental) and Norepinephrine group (active comparator).

The patients in this group will receive methylene blue bolus in addition to the norepinephrine infusion.

The patients in this group will receive norepinephrine infusion.

The registry classes the interventions as drug.

More on the Plan

The mortality rate of patients with septic shock remains very high.

Arterial hypotension, related to arteriolar vasodilation and myocardial depression are the mainstays of septic shock pathology.

Elevated levels of nitric oxide results in the blood vessel endothelium receiving direct vasodilator input, as well as the inability to respond to norepinephrine-mediated vasoconstriction.

The use of methylene blue has been recently advocated as a potential adjunct in the treatment of shock states.

Who Took Part

The registry lists 32 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: The patient is on norepinephrine infusion.

The full record lists 2 inclusion and 2 exclusion criteria.

How the Study Was Run

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 outcomes assessor.

It started in 2020-03-10 with completion listed for 2020-09-10.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Microvascular flow index (time frame: 6 hours).

It also tracked 9 secondary outcomes, for example Total vessel density, Perfused vessel density, Proportion of perfused vessel, mean arterial pressure, serum lactate and length of stay in the intensive care unit.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Methylene blue (non-peptide stack partner) in 32 people.

Its size is small, so on its own it can only give an early look.

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.