Methylene Blue-Enhanced Ultrafiltration Improves Outcomes After Cardiopulmonary Bypass

What Was Tested

The trial (phase 2) is built around Methylene blue (non-peptide stack partner).

Introduction: Fluid overload and systemic inflammation are major contributors to postoperative complications in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB).

Objective: To evaluate the effects of blood washing with methylene blue during zero-balance ultrafiltration (ZBUF) on fluid overload and systemic inflammatory response.

Methodology: Fluid status was assessed using the InBody S10 precision bioimpedance device, measuring extracellular water (ECW), total body water (TBW), intracellular water (ICW), and the ECW/TBW ratio.

It had three arms (groups): Conventional ultrafiltration (active comparator), Blood washing with physiological solution combined with zero-balance ultrafiltration (placebo comparator) and Methylene blue wash combined with zero-balanced ultrafiltration (experimental).

Conventional ultrafiltration (G-CUF) patients in this group underwent conventional ultrafiltration widely used in cardiac surgery with extracorporeal circulation.

Blood washing with physiological solution combined with zero-balanced ultrafiltration (G-ZBUF) patients in this group underwent zero-balanced ultrafiltration, and for this purpose, the simulation was performed with physiological solution.

The registry classes the interventions as drug and procedure.

Who Took Part

The registry lists 124 actual participants took part.

It was open to people of any sex aged from 20 years up to 60 years.

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

How the Study Was Run

The set-up was 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 2021-04-12 with completion listed for 2023-08-25.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Systemic Inflammation (time frame: Three years). Water overload (time frame: Three years). Intravascular volume assessment using IVC indices (time frame: Three years).

It also tracked 1 secondary outcome, for example Length of stay in the intensive care unit (ICU).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Methylene blue (non-peptide stack partner) in 124 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.