Staged Kidney Transplantation During Combined Heart/Kidney Transplantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Cedars-Sinai Medical Center
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Incidence of delayed graft function (DGF) of the kidney allograft
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Delayed implantation with ex vivo machine perfusion of kidney allograft.
Patients presenting for heart/kidney transplantation who consent to participate will be enrolled in this prospective, open-label, single-arm trial to undergo heart transplantation with planned delayed kidney transplantation with machine perfusion of the kidney allograft. Kidneys will be preserved using hypothermic oxygenated machine perfusion (HOPE) prior to transplantation. Timing of kidney implantation will be determined by recipient stability (e.g., vasopressor and inotrope requirements, coagulopathy, heart graft function) and allow for at least 6 hours of HOPE preservation. Both heart and kidney transplant procedures will follow standard of care techniques.
Intervention: Planned delayed implantation of kidney allograft with ex vivo machine perfusion kidney preservation. (Other)
Outcomes
Primary Outcomes
Incidence of delayed graft function (DGF) of the kidney allograft
Time Frame: 7 days
Delayed graft function (DGF) of the kidney allograft is defined as dialysis within the first 7 days post-transplant and will be monitored for all participants.
Number of patients with at least one adverse event
Time Frame: 90 days
Safety endpoint will be assessed by monitoring for adverse events associated with either heart or kidney allografts within 90-days of initial operative event. Adverse events may include graft primary non-function, wound infection, urinary tract infection, ventilator-associated pneumonia, return to operating room, etc. Complications will be reported by Clavien-Dindo classification and analyzed as both those relating directly to the kidney transplant as well as overall incidence.
Secondary Outcomes
- 12-month Kidney Allograft Function(12 months)
- Number of Patients with Heart Primary Graft Dysfunction(24 hours)
- 6 Month Kidney allograft function(6 months)
- Hospital Length of Stay(1 year)
- intensive care unit length of stay(1 year)
- Number of readmissions(90 days)
- Incidence of Kidney Allograft Rejection(1 year)
- Number of patients with Heart allograft rejection(1 year)
- 36-month kidney allograft function(36 months)
Investigators
Justin Steggerda
Assistant Professor of Surgery, Division of Abdominal Transplant Surgery
Cedars-Sinai Medical Center