NCT05743751

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

Prospective Randomized Controlled Study Normothermic Pulse Perfusion Comparing and Hypothermic Machine Perfusion in Margin Deceased Donor Kidney Transplantation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Zhang Tianyu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The main purpose of the study is to improve the utilization rate of marginal donors through normothermic perfusion, and reduce the incidence of infection, severe rejection and even graft failure caused by implantation of marginal donors. This study aims at the following aspects: 1. To compare the effects of two methods and perfusion parameters on the quality of marginal donors: normal temperature pulse perfusion and low temperature mechanical perfusion; 2. Explore the methods of evaluating the function of donor organs; 3. Exploring the effects of different mechanical perfusion methods and perfusion conditions on marginal donors; 4. The effect of broad-spectrum antibiotics on improving donor infection through different administration routes and different drug doses during perfusion and preservation. A single-center prospective randomized controlled study was used to compare the prognosis of renal transplantation between 50 patients with normothermic pulse perfusion and 50 patients with hypothermic mechanical perfusion who were enrolled in our hospital for allograft kidney transplantation. Assessment factors: 1. Donor parameters: age, sex, creatinine, diabetes, cause of death, length of stay in ICU, calcification of donor renal artery (CRP expression level) 2. Perfusion pressure, perfusion time, perfusion temperature, perfusion vessel resistance index 3. Receptor factors: age, gender, height, weight, BMI, cause of kidney disease (hypertension, diabetes glomerulonephritis, polycystic kidney disease), dialysis time (month), dialysis type (blood/peritoneum), HLA mismatch number, smoking, diabetes, hypertension, heart disease, hyperlipidemia, anemia, complication index (CCI), ASA score (\>3 or ≤ 3), operation time, number of donor renal artery branches, number of donor renal vein branches, donor creatinine, cold ischemia time (mins), and the perfusion of the transplanted kidney ( judged by the fluorescence intensity after indocyanine green injection). Laboratory results: PRA (panel-reactive antibody), blood creatinine, estimated glomerular filtration rate (eGFR), blood lactate level, postoperative urine volume. Graft loss, culture result of irrigation solution (bacteria). Sample acquisition: obtaining the blood and urine samples of the recipient and measuring the expression level of globulin A in the serum. In the process of kidney transplantation, the donor's renal artery vessel wall and the recipient's external iliac artery vessel wall were obtained. The blood vessel wall was stained with calcification, CRP to evaluate the calcification of the donor and recipient vessels.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-03-03
• Primary completion: 2024-12-03
• Completion: 2025-09-03
• First posted: 2023-02-24
• Last updated: 2023-02-24

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study