Staged Kidney Transplantation During Combined Heart/Kidney Transplantation
This study is looking at a new way to perform combined heart and kidney transplants for people with heart failure and severe kidney disease. It's testing a method called "staged implantation of kidney allografts with ex vivo machine perfusion kidney preservation." This means the new kidney is kept on a special machine that adds oxygen before it's implanted, and the kidney transplant might happen at a different time than the heart transplant. The study wants to see if this approach is safe and effective. You might be able to join if you are an adult (18 or older) having a combined heart and kidney transplant at Cedars-Sinai Medical Center. The study will consider it a success if fewer patients need dialysis in the first seven days after their kidney transplant and if there are not too many side effects within 90 days. The current recruitment status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 20 participants. It is not specified if it is randomized or blinded.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track kidney function for 7 days and adverse events for 90 days after transplantation.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Staged Kidney Transplantation During Combined Heart/Kidney Transplantation
At a glance
Conditions
NCT06877169
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Cedars-Sinai Medical Center
Los Angeles, Californiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Justin A Steggerda, M.D. · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center
Who to contact
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Inclusion
Exclusion
What this trial measures
- Incidence of delayed graft function (DGF) of the kidney allograft7 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 event90 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.