Study of Haemoadsorption Using CytoSorb During Heart Transplant Surgery to Reduce Inflammation and Improve Recovery

What this Trial Is About

This research aims to evaluate the effect of haemoadsorption HA on patients undergoing heart transplantation. It focuses on whether HA during cardiopulmonary bypass can alter circulating cytokine levels within the first 120 hours after transplantation, potentially reducing inflammation or boosting anti-inflammatory or immunosuppressive responses. The study also assesses HAs impact on complications like primary graft dysfunction, postoperative brain dysfunction, fluid buildup, kidney problems, time on mechanical ventilation, ICU stay length, and 30-day mortality. Participants are randomly assigned to one of two groups during surgery with cardiopulmonary bypass. The intervention group receives the CytoSorb adsorber device, which is connected in parallel to the bypass circuit and operates with a roller pump at 300-400 ml per minute flow to remove cytokines. The control group undergoes the same surgery without the adsorber filter installed. During the study, researchers will monitor cytokine peak levels including IL-1b2, IL-6, IL-33, TNF-b1, and IL-10 for five days after transplantation. They will also assess immunosuppression markers, primary graft dysfunction, delirium, mechanical ventilation duration, and mortality over varying periods up to 30 days or four weeks. The study includes single-blind monitoring and aims to provide detailed outcome data on inflammatory and clinical responses following heart transplantation with or without haemoadsorption.

Haemoadsorption During Heart Transplantation