Methylene Blue for the Prevention of Hypotension During Hemodialysis

What Was Tested

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

Hypotension is a common complication of intermittent renal replacement therapy.

It had two arms (groups): Methylene Blue (active comparator) and Control (other).

Methylene blue will be infused during renal replacement therapy.

Usual care.

The registry classes the interventions as drug and other.

More on the Plan

BLUE is a randomized, multicenter, open-label trial.

The usual care group will not receive any intervention.

A total of 260 patients are expected to be randomized in a 1:1 ratio.

Who Took Part

261 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: Patients over 18 years old. Acute kidney injury or acute-on-chronic kidney disease requiring intermittent renal replacement therapy hemodialysis. Systolic blood pressure lower than 100 mmHg or use of vasopressor. Signed informed consent.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: life expectancy less than 24 hours; exclusive palliative or end-of-life care; RRT due to hypertensive crisis.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

Nothing was hidden in this open-label Methylene blue (non-peptide stack partner) study: the participants and staff both knew the treatment.

It started in 2021-10-21 with completion listed for 2025-12-16.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Composite Endpoint (time frame: 6 hours).

It also tracked 7 secondary outcomes, for example Hypotension, RRT session fluid balance, 24-hour fluid balance, Mortality in the intensive care unit and Mortality in the hospital.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Methylene blue (non-peptide stack partner) in 261 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.