Evaluating in Cirrhotics With Refractory Vasoplegia the Effect of Methylene Blue

What Was Tested

The trial (phase 4) is built around Methylene blue (non-peptide stack partner).

Widespread vasodilatation involves the activation of the soluble intracellular enzyme guanylate cyclase (GC) by nitric oxide (NO), resulting in the production of cyclic guanosine monophosphate (cGMP).

Initially discovered as an endothelium-derived relaxing factor in blood vessels, NO is made by the enzyme nitric oxide synthase (NOS).

It had two arms (groups): Methylene Blue (experimental) and Standard Treatment (no intervention).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 111 actual participants took part.

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: Adult patients (\>18 years ).

The full record lists 2 inclusion and 11 exclusion criteria; among the exclusions: declined consent; less than 18 years old; immunosuppressant patients (e.g. on steroid medication, active anti-cancer chemotherapeutic agent, etc.).

How the Study Was Run

It was run as a randomized, sequential and double-blind study.

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.

Blinding on both sides kept the participants and researchers unaware of who received Methylene blue (non-peptide stack partner).

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2017-01-01 with completion listed for 2018-01-10.

It ran at 1 site in India.

Its stated primary purpose is supportive care.

What Was Measured

Researchers chose this as the main measure: Survival in both groups (time frame: 2 days).

It also tracked 3 secondary outcomes, for example Systemic Vascular Resistance and Mean Arterial Pressure.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Methylene blue (non-peptide stack partner) in 111 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.