NCT06877169

Staged Kidney Transplantation During Combined Heart/Kidney Transplantation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure
• Chronic Kidney Disease
• End-stage Kidney Disease

Interventions

Type	Name	Description
OTHER	Planned 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.

Timeline

• Start date: 2025-04-07
• Primary completion: 2027-02-28
• Completion: 2035-02-28
• First posted: 2025-03-14
• Last updated: 2025-06-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study