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NCT06877169NARecruiting

Staged Kidney Transplantation During Combined Heart/Kidney Transplantation

Cedars-Sinai Medical Center

Start Date

4/7/2025

Completion Date

2/28/2035

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.

Detailed 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 contributing to vasoconstriction, bleeding, hypotension, and worsening ischemia-reperfusion injury. Unfortunately, delaying implantation leads to extended cold ischemic time which also may be detrimental to the graft. Delayed graft function (DGF) of the kidney allograft is defined as the need for dialysis in the first seven days after transplantation and has been shown to be an important risk factor for graft loss following H/KTx. Ultimately, H/KTx requires balancing recipient stability with cold ischemic time to optimize kidney graft function. New perfusion technology adds oxygenation to the perfusate of the kidney allograft, thereby resuscitating the organ during preservation and reducing ischemia-reperfusion injury. This study seeks to evaluate the safety and efficacy of planned delayed implantation to allow for improved recipient stability and coagulopathy, while using hypothermic oxygenated machine perfusion (HOPE) for kidney preservation.

Eligibility Criteria

Age Range: 18 years to No maximum

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

OTHER

Planned delayed implantation of kidney allograft with ex vivo machine perfusion kidney preservation.

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Conditions

Heart FailureChronic Kidney DiseaseEnd-stage Kidney Disease

Locations

Cedars-Sinai Medical Center

Los Angeles, California 90048

United States