Machine Preservation for Kidney Disease

Recruiting in Palo Alto (17 mi)

Overseen byJustin A Steggerda, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Cedars-Sinai Medical Center

No Placebo Group

Trial Summary

What is the purpose of 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 is for patients with severe heart and kidney conditions who need both a heart and kidney transplant. They should be stable enough to undergo staged surgeries, first receiving the heart then the kidney after some time.

Inclusion Criteria

I am an adult scheduled for heart and kidney transplant at Cedars-Sinai.

Exclusion Criteria

Patients with medical records flagged as 'break-the-glass' or 'research opt-out' within the center's electronic health record.

I have not had a heart and kidney transplant at the same time.

Participant Groups

The study tests if keeping a donated kidney on a machine that mimics body conditions (ex vivo perfusion) before implantation is safe and works well when done in stages during combined heart/kidney transplants.

1Treatment groups

Experimental Treatment

Group I: Delayed implantation with ex vivo machine perfusion of kidney allograft.Experimental Treatment1 Intervention

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.