Staged Kidney Transplantation During Combined Heart/Kidney Transplantation
Cedars-Sinai Medical Center
Summary
The primary purpose of this study is to evaluate the safety and efficacy of ex vivo machine perfusion with staged implantation of kidney allografts during combined heart/kidney transplantation.
Description
Combined heart and kidney transplantation (H/KTx) is the treatment of choice for patients with concomitant heart failure and chronic- or end-stage kidney disease. H/KTx presents a logistical challenge, often involving multiple surgical teams and requiring extended operative time to perform both heart and kidney transplants. Additionally, during heart transplantation, recipients require anticoagulation and multiple inotropes and vasopressors to support heart function early after implantation. While necessary, these may be detrimental to the newly implanted kidney allograft, potentially contribu…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adult patients (18 years or older) undergoing combined heart and kidney transplantation at Cedars-Sinai Medical Center. Exclusion Criteria: * Patients who undergo simultaneous heart/kidney transplantation in a single operative event due to medical necessity will be excluded. * Patients with medical records flagged as "break-the-glass" or "research opt-out" within the center's electronic health record.
Interventions
- OtherPlanned delayed implantation of kidney allograft with ex vivo machine perfusion kidney preservation.
During combined heart and kidney transplantation, heart and kidney allografts may be implanted during a single operative event, or with delayed kidney implantation in a second operative event. Timing of the delay is often determined by recipient stability and kidney availability; however, clinicians must balance recipient factors with accumulating cold ischemic time of the kidney allograft. This study uses hypothermic oxygenated machine perfusion to reduce ischemic injury to the kidney allograft and allow for improved recipient stability with planned delayed implantation of the kidney graft. Delays will allow for at least 6 hours of hypothermic oxygenated machine perfusion prior to implantation.
Location
- Cedars-Sinai Medical CenterLos Angeles, California