NCT Number: NCT06877169
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Los Angeles, California, 90048, United States
Location status: Recruiting
Justin A Steggerda, M.D.
CONTACT
Justin A Steggerda, M.D.
PRINCIPAL_INVESTIGATOR
Steven A Wisel, M.D.
SUB_INVESTIGATOR
Tyler Gunn, M.D.
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: 24 hours
Primary graft dysfunciton (PGD) of the heart allograft after transplant is defined as left ventricle, right ventricle, or biventricular dysfunction that occurs within 24 hours after surgery and is not associated with a discernible cause such as hyperacute rejection, pulmonary hypertension, massive blood product transfusion during surgery, or prolonged graft ischemic time. Grading will be done according to International Society of Heart and Lung Transplantation guidelines.
Time frame: 6 months
Kidney function will be determined by estimated glomerular filtration rate at 6 months post-transplant.
Time frame: 12 months
Kidney function will be determined by estimated glomerular filtration rate at 12 months post-transplant.
Time frame: 1 year
Patient intensive care unit length of stay following combined heart and kidney transplantation will be determined from date of transplant until date of transfer from intensive care unit to the patient ward.
Time frame: 1 year
The duration of post-transplant hospital length of stay will be measured from day of transplant until day of discharge or death, up to 1 year post-transplant.
Time frame: 90 days
Patients will be assessed for number of readmissions following initial discharge during the first 90 days after combined heart and kidney transplantation.
Time frame: 1 year
Incidence of kidney rejection will be evaluated during the first post-transplant year. Rejection will be determined by biopsy findings and type of rejection (cell-mediated vs antibody mediated vs mixed) will be recorded.
Time frame: 1 year
Incidence of heart rejection will be evaluated during the first post-transplant year. Rejection will be determined by biopsy findings and type of rejection (cell-mediated vs antibody mediated vs mixed) will be recorded.
Time frame: 36 months
Long-term graft function and survival will be assessed by estimated glomerular filtration rate (eGFR) at 3-years post-transplant. Graft loss before 3-years will be determined by death or return to dialysis and will be recorded in lieu of graft function.
Contact information is provided by the study sponsor or research team.
Justin A Steggerda, M.D.
CONTACT
Noriko Ammerman, Pharm.D.
CONTACT
Cedars-Sinai Medical Center
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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