Clinical trial NCT06877169: Staged Kidney Transplantation During Combined Heart/Kidney Transplantation
Official title: Staged Kidney Transplantation During Combined Heart/Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Chronic Kidney Disease
End-stage Kidney Disease
Keywords: combined heart and kidney transplant
simultaneous heart and kidney transplant
hypothermic oxygenated machine perfusion
organ preservation
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Incidence of delayed graft function (DGF) of the kidney allograft
timeFrame: 7 days
measure: Number of patients with at least one adverse event
timeFrame: 90 days
Secondary outcomes:
measure: Number of Patients with Heart Primary Graft Dysfunction
timeFrame: 24 hours
measure: 6 Month Kidney allograft function
timeFrame: 6 months
measure: 12-month Kidney Allograft Function
timeFrame: 12 months
measure: intensive care unit length of stay
timeFrame: 1 year
measure: Hospital Length of Stay
timeFrame: 1 year
measure: Number of readmissions
timeFrame: 90 days
measure: Incidence of Kidney Allograft Rejection
timeFrame: 1 year
measure: Number of patients with Heart allograft rejection
timeFrame: 1 year
measure: 36-month kidney allograft function
timeFrame: 36 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Justin A Steggerda, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kobashigawa J, Zuckermann A, Macdonald P, Leprince P, Esmailian F, Luu M, Mancini D, Patel J, Razi R, Reichenspurner H, Russell S, Segovia J, Smedira N, Stehlik J, Wagner F; Consensus Conference participants. Report from a consensus conference on primary graft dysfunction after cardiac transplantation. J Heart Lung Transplant. 2014 Apr;33(4):327-40. doi: 10.1016/j.healun.2014.02.027. Epub 2014 Mar 5.
citation: Jochmans I, Brat A, Davies L, Hofker HS, van de Leemkolk FEM, Leuvenink HGD, Knight SR, Pirenne J, Ploeg RJ; COMPARE Trial Collaboration and Consortium for Organ Preservation in Europe (COPE). Oxygenated versus standard cold perfusion preservation in kidney transplantation (COMPARE): a randomised, double-blind, paired, phase 3 trial. Lancet. 2020 Nov 21;396(10263):1653-1662. doi: 10.1016/S0140-6736(20)32411-9.
citation: Lutz AJ, Nagaraju S, Sharfuddin AA, Garcia JP, Saleem K, Mangus RS, Goggins WC. Simultaneous Heart-kidney Transplant With Planned Delayed Implantation of the Kidney Graft After Ex Vivo Perfusion. Transplantation. 2023 Sep 1;107(9):2043-2046. doi: 10.1097/TP.0000000000004661. Epub 2023 Jun 5.
citation: Ruzza A, Czer LS, Trento A, Esmailian F. Combined heart and kidney transplantation: what is the appropriate surgical sequence? Interact Cardiovasc Thorac Surg. 2013 Aug;17(2):416-8. doi: 10.1093/icvts/ivt172. Epub 2013 Apr 24.