Evaluating Safety and Effectiveness of Delayed Kidney Transplant During Combined Heart and Kidney Transplant Surgery Using Machine Perfusion

What this Trial Is About

This research focuses on patients with heart failure and chronic or end-stage kidney disease who need both heart and kidney transplants. The study evaluates a method that uses ex vivo machine perfusion with planned delayed kidney implantation during combined heartkidney transplantation to improve safety and effectiveness. This approach aims to balance patient stability and reduce injury to the kidney graft during the transplant process. Participants will undergo combined heart and kidney transplantation where the kidney transplant is delayed and preserved using hypothermic oxygenated machine perfusion HOPE for at least six hours before implantation. The timing of kidney implantation depends on the patients stability, including factors like heart graft function and medication needs. Both heart and kidney transplant surgeries follow standard procedures. During the study, participants will be closely monitored for kidney function, including delayed graft function defined as the need for dialysis within seven days after transplant. Researchers will track adverse events for 90 days and assess heart and kidney graft function at multiple time points up to 36 months. Hospital and intensive care unit stays, readmissions, and rejection episodes will also be recorded. The study period extends through to 2035, with detailed follow-up evaluations.

Staged Kidney Transplantation During Combined Heart/Kidney Transplantation