Staged Kidney Transplantation During Combined Heart/Kidney Transplantation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCedars-Sinai Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (18 years or older) undergoing combined heart and kidney transplantation at Cedars-Sinai Medical Center.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Planned delayed implantation of kidney allograft with ex vivo machine perfusion kidney preservation.
Other interventionDuring 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Delayed implantation with ex vivo machine perfusion of kidney allograft.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of delayed graft function (DGF) of the kidney allograft
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
7 days2
Number of patients with at least one adverse event
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
90 daysSecondary outcomes
1
Number of Patients with Heart Primary Graft Dysfunction
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
24 hours2
6 Month Kidney allograft function
Kidney function will be determined by estimated glomerular filtration rate at 6 months post-transplant.
Time frame
6 months3
12-month Kidney Allograft Function
Kidney function will be determined by estimated glomerular filtration rate at 12 months post-transplant.
Time frame
12 months4
intensive care unit length of stay
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 yearSponsors and contacts
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Source ClinicalTrials.gov