MedTrace Logo

Normothermic Machine Perfusion (NMP) Versus Hypothermic Machine Perfusion (HMP) in Human Kidney Transplantation

NCT05743751 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-02-24

No results posted yet for this study

Summary

Due to the rising incidence of renal failure and the improvement of organ transplantation technology, the shortage of donor organs has become one of the main problems limiting the development of kidney transplantation. Marginal donor is one of the important ways to extend the donor pool. Normothermic mechanical perfusion (NMP) is a new generation of organ preservation technology, which can maintain the blood supply and at the same time evaluate the marginal kidney function during the organ preservation. However, the clinical effect has not been proved. Hypothermic Machine Perfusion (HMP) is the mainstream organ perfusion technology. This study aims to compare the effectiveness of NMP with the HMP.

Conditions

  • Kidney Transplantation

Interventions

DEVICE

Normothermic machine perfusion

XVIVO (perfusion company, Gothenburg, Sweden), functions to be included in perfusion equipment, cardiopulmonary bypass machine and neonatal cardiopulmonary bypass machine, including polyethylene pipeline, heating equipment (perfusion temperature 37 ℃), venous pool (venous pressure is 0 mmHg, adjust the height of perfusion pool), centrifugal pump (arterial pressure is set at initial 75 mmHg, maintain 65 mmHg). The perfusion solution contains 215ml of dextran/albumin solution and 400ml of hematocrit, 2ml of 10% calcium gluconate, 1300u/L heparin and 400mg of cefazolin sodium. The oxygen/carbon dioxide ratio is (95%/5%, 2L/min) for continuous perfusion, and pO2 is maintained at 650mmHg during perfusion. During perfusion, continue to use verapamil, amino acid, glucose and insulin. Lactic acid Ringer solution (10ml/h) was used to supplement the lost circulation volume due to urine production during perfusion.

DEVICE

Hypothermic machine perfusion

LifePort Kidney Transporter is designed to integrate with the clinical environment by using readily available supplies, requiring minimal user intervention, and by being easy to use. LifePort Kidney Transporter is a portable, isolated kidney perfusion and transport system, designed to support a donated kidney and to maintain the organ in a near-normal physiologic state under hypothermic aseptic conditions. An insulated plastic housing encloses the kidney and perfusate within a LifePort Kidney Transporter Disposable Perfusion Circuit. LifePort Kidney Transporter components include an Ice Container, Pump Deck, Control Panel, Outer Display, Bubble Detectors, External Connections Panel, sensors, and four lithium-ion batteries. Two handles make the unit easy to lift and carry

Sponsors & Collaborators

  • Zhang Tianyu

    lead OTHER

Principal Investigators

  • Zhou Xiaofeng, MD · China-Japan Friendship Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-03
Primary Completion
2024-12-03
Completion
2025-09-03
FDA Device
Yes

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05743751 on ClinicalTrials.gov