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

Not Applicable

Completed

• Conditions: Organ Preservation; Kidney Transplantation
• Interventions: Device: LifePort transrenal vein perfusion; Device: LifePort transrenal artery perfusion

• Registration Number: NCT04569682
• Lead Sponsor: West China Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-09-21
• Study First Submitted QC: 2020-09-29
• Study First Posted: 2020-09-30
• Primary Completion: 2021-10-30
• Study Completion: 2022-12-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-19
• Last Update Posted: 2023-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

1. Adult recipients older than 18 years;
2. 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;
3. First single kidney transplantation;
4. The recipients can understand the purpose and risk of deceased kidney transplantation and sign informed consent;
5. Ethics committee approved.

Exclusion Criteria

1. Patients less than 18 years old, or more than 65 years old;
2. Patients who receive multiple organ transplants;
3. Diagnosed with malignancy or had a history of malignancy in the past 5 years;
4. non-kidney transplantation history.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transrenal vein perfusion group	LifePort transrenal vein perfusion	-
transrenal artery perfusion group	LifePort transrenal artery perfusion	-

Primary Outcome Measures

Name	Time	Method
Delayed graft function	Within one week posttransplantation	Delayed graft function is defined as the need for dialysis (for any cause) within the first week posttransplantation.

Secondary Outcome Measures

Name	Time	Method
Graft loss	One year after transplantation	Graft loss was defined as re-establishment of long-term dialysis or estimated glomerular filtration rate (eGFR) of \<15 ml/min.
biopsy-confirmed acute rejection	One year after transplantation	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.

Trial Locations

Locations (1)

West China Hospital, Sichuan University; 🇨🇳 Chengdu, China