drugset / Trial / NCT07212842

Methylene Blue-Enhanced Ultrafiltration Improves Outcomes After Cardiopulmonary Bypass

NCT07212842

Phase 2 Completed 124 enrolled University of Sao Paulo
RandomizedParallel-groupSingle-blindTreatment

Summary

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. Pulmonary congestion and intravascular volume were evaluated separately using a Philips Lumify S4-1 transducer with a Samsung tablet. Pulmonary congestion was confirmed by the presence of B-lines on lung ultrasound. Intravascular volume was assessed via the inferior vena cava (IVC) distensibility index (DI) during mechanical ventilation and collapsibility index (CI) during spontaneous breathing. Inflammatory cytokine levels were measured using a Luminex xMAP-based multiplex immunoassay.

Timeline

Start
2021-04-12
Primary completion
2023-08-25
Completion
2024-03-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylene Blue Diagnostic / imaging agent 1 mg/kg