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METHYLENE BLUE-ENHANCED BLOOD WASHING DURING ZERO-BALANCE ULTRAFILTRATION REDUCES FLUID OVERLOAD AND INFLAMMATORY RESPONSE FOLLOWING CARDIOPULMONARY BYPASS: A RANDOMIZED CLINICAL TRIAL
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.
Age
20 - 60 years
Sex
ALL
Healthy Volunteers
No
University of São Paulo Medical School in Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil
Start Date
April 12, 2021
Primary Completion Date
August 25, 2023
Completion Date
March 16, 2024
Last Updated
October 8, 2025
124
ACTUAL participants
Methylene Blue
DRUG
Conventional ultrafiltration
PROCEDURE
Zero-balance ultrafiltration
PROCEDURE
Lead Sponsor
University of Sao Paulo
NCT07360899
NCT07286227
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