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

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04569682
• Other study ID #: WestChina-LifePort
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: May 2023
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 30, 2022
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Death
• Kidney Transplantation
• Organ Preservation

Intervention

Device:
• LifePort transrenal artery perfusion
transrenal artery perfusion group
• LifePort transrenal vein perfusion
transrenal vein perfusion group

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	Chengdu

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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