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

Primary Purpose

Kidney Transplantation

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Normothermic machine perfusion
Hypothermic machine perfusion
Sponsored by
Zhang Tianyu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Transplantation focused on measuring Kidney Transplantation, Normothermic Machine Perfusion, Hypothermic Machine Perfusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18-60 years old, gender unlimited Volunteer to participate in this clinical trial and sign the informed consent form Suffering from end-stage renal disease Planned kidney transplantation The expanded standard donors (ECD) were obtained The expanded standard kidney donor is defined as: aged cadaver donors over 60 years old or two or three of the following conditions between 50 and 60 years old: death due to cerebrovascular disease; Hypertension; The blood creatinine level before donation was greater than 133umol/L. Exclusion Criteria: Active infection Living donor kidney recipient Acute rejection Second kidney transplantation Combined transplantation (combined liver and kidney, combined pancreas and kidney) Patients who take other clinical trial drugs or participate in other clinical studies Unable to continue the research Patients who are judged by the researcher to be unsuitable for this clinical trial

Sites / Locations

  • China-Japan Friendship Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Hypothermic machine perfusion

Normothermic machine perfusion

Arm Description

After organ acquisition, the donor kidney was trimmed, and then the donor kidney was connected to the cryoperfusion machine (lifeport, which has been used in routine clinical practice in our hospital) for continuous low temperature mechanical perfusion (<8 ℃). The perfusion solution was extracted for proteomic study at 10 min after perfusion and at the end of perfusion.

After conventional UW perfusion is obtained, the marginal donor kidney is immediately perfused without ischemia at normal temperature. The perfusion time is at least 4 hours (so as to repair the marginal donor kidney). The perfusion solution is as above, and the perfusion solution is loaded into the device authorized in Europe (XVIVO - KidneyAssist ®), Connect the transplanted renal artery with the device. Take 5ml perfusion solution in advance before perfusion, 5ml perfusion solution every 30min after perfusion, take perfusion solution at the end of perfusion (blood gas analysis for each perfusion solution, and finally perfusion solution for culture), and measure urine volume every hour. After perfusion, the transplanted kidney was disconnected from the perfusion device, and the donor kidney was perfused again with 2L HTK solution, followed by routine transplantation.

Outcomes

Primary Outcome Measures

Rate of delayed renal function (DGF)
At least one dialysis is required within one week after kidney transplantation

Secondary Outcome Measures

Estimated glomerular filtration rate
Calculated from serum creatinine levels to assess kidney function.
Rate of primary non-function (PNF)
Dialysis is required because the transplanted kidney is nonfunctional
Graft survival and recipient survival
Incidence of the Graft survival and recipient survival
Complications
incidence of complications
Patient death
Death date after surgery and the reasons

Full Information

First Posted
January 28, 2023
Last Updated
February 14, 2023
Sponsor
Zhang Tianyu
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1. Study Identification

Unique Protocol Identification Number
NCT05743751
Brief Title
Normothermic Machine Perfusion (NMP) Versus Hypothermic Machine Perfusion (HMP) in Human Kidney Transplantation
Official Title
Prospective Randomized Controlled Study Normothermic Pulse Perfusion Comparing and Hypothermic Machine Perfusion in Margin Deceased Donor Kidney Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 3, 2023 (Anticipated)
Primary Completion Date
December 3, 2024 (Anticipated)
Study Completion Date
September 3, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhang Tianyu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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: 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; Explore the methods of evaluating the function of donor organs; Exploring the effects of different mechanical perfusion methods and perfusion conditions on marginal donors; 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: Donor parameters: age, sex, creatinine, diabetes, cause of death, length of stay in ICU, calcification of donor renal artery (CRP expression level) Perfusion pressure, perfusion time, perfusion temperature, perfusion vessel resistance index 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplantation
Keywords
Kidney Transplantation, Normothermic Machine Perfusion, Hypothermic Machine Perfusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Participant and care provider were blinded to the interventions.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypothermic machine perfusion
Arm Type
Active Comparator
Arm Description
After organ acquisition, the donor kidney was trimmed, and then the donor kidney was connected to the cryoperfusion machine (lifeport, which has been used in routine clinical practice in our hospital) for continuous low temperature mechanical perfusion (<8 ℃). The perfusion solution was extracted for proteomic study at 10 min after perfusion and at the end of perfusion.
Arm Title
Normothermic machine perfusion
Arm Type
Experimental
Arm Description
After conventional UW perfusion is obtained, the marginal donor kidney is immediately perfused without ischemia at normal temperature. The perfusion time is at least 4 hours (so as to repair the marginal donor kidney). The perfusion solution is as above, and the perfusion solution is loaded into the device authorized in Europe (XVIVO - KidneyAssist ®), Connect the transplanted renal artery with the device. Take 5ml perfusion solution in advance before perfusion, 5ml perfusion solution every 30min after perfusion, take perfusion solution at the end of perfusion (blood gas analysis for each perfusion solution, and finally perfusion solution for culture), and measure urine volume every hour. After perfusion, the transplanted kidney was disconnected from the perfusion device, and the donor kidney was perfused again with 2L HTK solution, followed by routine transplantation.
Intervention Type
Device
Intervention Name(s)
Normothermic machine perfusion
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Hypothermic machine perfusion
Intervention Description
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
Primary Outcome Measure Information:
Title
Rate of delayed renal function (DGF)
Description
At least one dialysis is required within one week after kidney transplantation
Time Frame
1 week after surgery
Secondary Outcome Measure Information:
Title
Estimated glomerular filtration rate
Description
Calculated from serum creatinine levels to assess kidney function.
Time Frame
3, 6, 12 months after surgery
Title
Rate of primary non-function (PNF)
Description
Dialysis is required because the transplanted kidney is nonfunctional
Time Frame
1 months after surgery
Title
Graft survival and recipient survival
Description
Incidence of the Graft survival and recipient survival
Time Frame
1 year follow-up
Title
Complications
Description
incidence of complications
Time Frame
within 90 days after operation
Title
Patient death
Description
Death date after surgery and the reasons
Time Frame
1 year follow-up
Other Pre-specified Outcome Measures:
Title
Hospitalization expenses
Description
Total expenses of kidney transplantation
Time Frame
3, 6, 12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-60 years old, gender unlimited Volunteer to participate in this clinical trial and sign the informed consent form Suffering from end-stage renal disease Planned kidney transplantation The expanded standard donors (ECD) were obtained The expanded standard kidney donor is defined as: aged cadaver donors over 60 years old or two or three of the following conditions between 50 and 60 years old: death due to cerebrovascular disease; Hypertension; The blood creatinine level before donation was greater than 133umol/L. Exclusion Criteria: Active infection Living donor kidney recipient Acute rejection Second kidney transplantation Combined transplantation (combined liver and kidney, combined pancreas and kidney) Patients who take other clinical trial drugs or participate in other clinical studies Unable to continue the research Patients who are judged by the researcher to be unsuitable for this clinical trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhou Xiaofeng, MD
Phone
17310336871
Email
13911250201@139.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhou Xiaofeng, MD
Organizational Affiliation
China-Japan Friendship Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tianyu Zhang, MD
Phone
13911250201
Email
13911250201@139.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected IPD, all IPD that underlie results in a publication
IPD Sharing Time Frame
one year after research end
IPD Sharing Access Criteria
share the data
Citations:
PubMed Identifier
29683999
Citation
Hamar M, Urbanellis P, Kaths MJ, Kollmann D, Linares I, Ganesh S, Wiebe A, Cen JY, Yip P, John R, Konvalinka A, Mucsi I, Ghanekar A, Bagli D, Grant D, Robinson LA, Selzner M. Normothermic Ex Vivo Kidney Perfusion Reduces Warm Ischemic Injury of Porcine Kidney Grafts Retrieved After Circulatory Death. Transplantation. 2018 Aug;102(8):1262-1270. doi: 10.1097/TP.0000000000002245.
Results Reference
background
PubMed Identifier
23433047
Citation
Nicholson ML, Hosgood SA. Renal transplantation after ex vivo normothermic perfusion: the first clinical study. Am J Transplant. 2013 May;13(5):1246-52. doi: 10.1111/ajt.12179. Epub 2013 Feb 22.
Results Reference
background
PubMed Identifier
35238854
Citation
Mazilescu LI, Urbanellis P, Kim SJ, Goto T, Noguchi Y, Konvalinka A, Reichman TW, Sayed BA, Mucsi I, Lee JY, Robinson LA, Ghanekar A, Selzner M. Normothermic Ex Vivo Kidney Perfusion for Human Kidney Transplantation: First North American Results. Transplantation. 2022 Sep 1;106(9):1852-1859. doi: 10.1097/TP.0000000000004098. Epub 2022 Mar 1.
Results Reference
background

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

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