The Effect of Early Use of Methylene Blue on Hemodynamics in Septic Shock

What Was Tested

This registered not phased trial tested Methylene blue (non-peptide stack partner).

The patients will be randomized into two groups, the study protocol is early combined application of methylene blue.

The primary outcome is Sequential Organ Failure Assessment (SOFA) score 72 hours after admission.

It had two arms (groups): MB group (experimental) and control group (no intervention).

This group will be given conventional vasopressors, except methylene blue, based on the attending doctor's decision.

The registry classes the interventions as drug.

More on the Plan

The guidelines recommend NA as the first-line vasopressor.

Intervention: The patients will be randomized into two groups.

The control group received conventional treatments, the attending physicians decide the protocol of vasopressors.

Before and 6h after meeting the inclusion standard, sublingual microcirculation and automated function imaging of myocardium will be performed. 3.

Who Took Part

106 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 1 inclusion and 9 exclusion criteria; among the exclusions: pregnant women; without internal jugular vein or subclavian vein catheterization; child-pugh grade c with liver cirrhosis.

How the Study Was Run

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

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.

Only one side, usually the participants, was kept unaware of whether Methylene blue (non-peptide stack partner) was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2021-06-20 with completion listed for 2023-06-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): SOFA score (time frame: 72 hours).

It also tracked 1 secondary outcome, for example duration of shock.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Methylene blue (non-peptide stack partner) in 106 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.