Staged kidney implantation with hypothermic oxygenated machine perfusion during combined heart and kidney transplants
Staged Kidney Transplantation During Combined Heart/Kidney Transplantation
NA · Cedars-Sinai Medical Center · NCT06877169
This trial will test whether keeping the donor kidney on oxygenated machine perfusion and implanting it later helps adults who are receiving both a heart and a kidney transplant.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center (other) |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06877169 on ClinicalTrials.gov |
What this trial studies
Combined heart and kidney transplantation treats patients with advanced heart failure and kidney disease but poses logistical and physiologic challenges that can harm the kidney graft. Anticoagulation, inotropes, and hemodynamic instability during heart implantation can worsen ischemia-reperfusion injury, while delaying implantation increases cold ischemic time. This study uses hypothermic oxygenated ex vivo machine perfusion to preserve the donor kidney and implements a planned delayed (staged) implantation to allow recipient stabilization after heart transplant. Outcomes include safety endpoints and measures of kidney graft function such as incidence of delayed graft function and need for dialysis in the first week.
Who should consider this trial
Good fit: Ideal candidates are adults at Cedars-Sinai scheduled for a planned combined heart and kidney transplant who can undergo staged (delayed) kidney implantation and have not opted out of research.
Not a fit: Patients who require immediate simultaneous heart and kidney implantation for medical necessity, those flagged as research opt-out in the electronic record, or those unable to return for post-operative follow-up are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could reduce delayed graft function and improve early kidney graft survival after combined heart-kidney transplants.
How similar studies have performed: Hypothermic oxygenated machine perfusion has shown promise in reducing ischemia-reperfusion injury and delayed graft function in other kidney transplant settings, but planned delayed implantation during combined heart-kidney transplantation is relatively novel with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California, United States (RECRUITING)
Study contacts
- Principal investigator: Justin A Steggerda, M.D. — Cedars-Sinai Medical Center
- Study coordinator: Justin A Steggerda, M.D.
- Email: justin.steggerda@cshs.org
- Phone: 310-423-3276
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure, Chronic Kidney Disease, End-stage Kidney Disease, combined heart and kidney transplant, simultaneous heart and kidney transplant, hypothermic oxygenated machine perfusion, organ preservation