NCT02621281

Clinical Impact of Hypothermic Machine Perfusion in Renal Transplant Recipients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-centers prospective, randomized, controlled trial. This trial will investigate the clinical outcome of kidney transplant recipients whose kidneys are under two different forms of organ preservation--hypothermic machine perfusion vs. static cold storage. Factors during the machine perfusion, such as the pressure, flow rate, and resistance index will also be investigated.

Detailed description

In this randomized clinical trial, 200 kidney pairs from deceased donors will be included in the study, which will be randomly assigned, one kidney to machine perfusion and the other to cold storage. All 400 patients will be followed for 1 year. The primary endpoint is delayed graft function (requiring dialysis in the first week after transplantation) and duration of delayed graft function. The second endpoints: GFR at week 1, month3, month6 and month 12 post-transplant.

Conditions

• Delayed Function of Renal Transplant

Interventions

Type	Name	Description
DEVICE	Kidney Transporter machines	Kidney Transporter gently pumps the special cold solution through the kidney which outside the body.
DEVICE	cold storage	The kidneys procurement from the donor will be cold stored using some cold preservation solution.

Timeline

• Start date: 2015-12-01
• Primary completion: 2018-01-01
• Completion: 2019-01-01
• First posted: 2015-12-03
• Last updated: 2017-05-15

Locations

1 site across 1 country: China