Outcomes of Transrenal Artery Perfusion Versus Transrenal Vein Perfusion Using LifePort for Deceased Donor Kidney Transplantation

Study Overview
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Brief Summary
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The main objective of this study is to compare the outcomes of transrenal artery perfusion versus transrenal vein perfusion using LifePort for deceased donor kidney transplantation. Patients registered in the National Dialysis and Transplant Registry awaiting deceased donor kidney transplantation were included. Delayed graft function (DGF) or primary nonfunction (PNF) may occur after deceased donor kidney transplantation. Compared with static cold storage, the application of LifePort can significantly reduce the incidence of DGF and PNF in deceased donor kidney transplantation. Transrenal artery perfusion is currently the mainstream but confronts multiple renal arteries, resulted in prolonged cold ischemia time. Transrenal vein perfusion is expected to be a solution. However, whether the clinical outcomes of transrenal vein perfusion is inferior to transrenal artery perfusion remains unknown. In this study, values of urine volume and creatinine, incidence and duration of DGF, and incidence of PNF within 1 week after surgery are recorded and compared between the transrenal artery perfusion group and the transrenal vein perfusion group. Monthly eGFR and creatinine values, the incidence of acute rejection within 1 year after transplantation and 1-year graft and patient survival are also recorded and compared.

Official Title
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Outcomes of Transrenal Artery Perfusion Versus Transrenal Vein Perfusion Using LifePort for Deceased Donor Kidney Transplantation

Conditions
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Kidney Transplantation, Organ Preservation

Intervention / Treatment
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* Device: LifePort transrenal artery perfusion
* Device: LifePort transrenal vein perfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult recipients older than 18 years; Patients diagnosed with end-stage renal diseases and volunteered to register in the Transplant and Dialysis Registry of China awaiting for deceased donor kidney transplantation; First single kidney transplantation; The recipients can understand the purpose and risk of deceased kidney transplantation and sign informed consent; Ethics committee approved. Exclusion Criteria: Patients less than 18 years old, or more than 65 years old; Patients who receive multiple organ transplants; Diagnosed with malignancy or had a history of malignancy in the past 5 years; non-kidney transplantation history.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: transrenal artery perfusion group<br> | Device: LifePort transrenal artery perfusion<br>* transrenal artery perfusion group<br>|
| Experimental: transrenal vein perfusion group<br> | Device: LifePort transrenal vein perfusion<br>* transrenal vein perfusion group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delayed graft function | Delayed graft function is defined as the need for dialysis (for any cause) within the first week posttransplantation. | Within one week posttransplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft loss | Graft loss was defined as re-establishment of long-term dialysis or estimated glomerular filtration rate (eGFR) of <15 ml/min. | One year after transplantation | 
| biopsy-confirmed acute rejection | biopsy-confirmed acute rejection was diagnosed clinically based on a significant increase in serum creatinine levels of 50% or more within 3 days, which was not explained by other reasons and confirmed by biopsy. | One year after transplantation |