Clinical Impact of Hypothermic Machine Perfusion in Renal Transplant Recipients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Impact of Hypothermic Machine Perfusion in Renal Transplant Recipients

Conditions
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Delayed Function of Renal Transplant

Intervention / Treatment
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* Device: Kidney Transporter machines
* Device: cold storage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Donor Comply with the national DCD（donor after citizen death) guideline No high risk activities: such as history of drug abuse, history of intravenous drug use and risky sexual behavior No malignant melanoma, metastatic cancer, or incurable cancer; some of the early stages of cancer after a successful treatment can also be considered No active, untreated systemic bacterial, viral or fungal infection; Patients definitely identified Mechanical perfusion RI (resistance index ) [0.18, 0.50] Recipient: Age> = 16 years old, male or female BMI<28 First Renal transplantation Not in pregnancy or lactation, pregnancy test was negative, and promise not to be pregnant during treatment. Before the clinical trial, Patient sign informed consent voluntarily Exclusion Criteria: Donor Older than 50 years old Serum HBV (hepatitis B virus), HCV (hepatitis C virus), HIV positive Donor kidney cold storage time over 30 hours Warm ischemia time over 20 minutes Other reagents are added perfusion for regulation of donor renal function Recipient: Double organ or multi-organ transplant Blood type-incompatible Patients with other malignant diseases

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: cold storage<br>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. In machine perfusion group, patients will be analyzed by two subgroups based on pressure, resistance index and perfusion time duration. | Device: cold storage<br>* The kidneys procurement from the donor will be cold stored using some cold preservation solution.<br>|
| Active Comparator: Kidney Transporter machines<br>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. In machine perfusion group, patients will be analyzed by two subgroups based on pressure, resistance index and perfusion time duration. | Device: Kidney Transporter machines<br>* Kidney Transporter gently pumps the special cold solution through the kidney which outside the body.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of Delayed graft function | Delayed graft function (DGF) is a common complication of renal transplantation. DGF can be diagnosed according to the three aspects below. i. Need for postoperative dialysis: Need for dialysis in the first week after transplant once hyperacute rejection, vascular and urinary tract complications and hyperkalemia are ruled out. ii. Urine output and serum creatinine: 1) Rise in serum Cr at 6-8 h post-operatively or <300 ml of urine despite adequate volume and diuretics. 2) Urine output <1 L in 24 h and <25% fall in serum creatinine from baseline in first 24 h post-transplant. 3) Urine output <75 mL/h in first 48 h or failure of serum Cr to decrease by 10% in the first 48 h. 4) Serum creatinine increases or remains unchanged or decreases <10%/day during 3 consecutive days postoperatively. 5) Serum creatinine >2.5mg/dL on Day 7 or need for post-transplant hemodialysis.6) Time required for the kidney to reach CrCl>10 mL/min greater than 1 week. | the first week after transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated Glomerular Filtration Rate | Glomerular filtration rate (GFR) is the volume of fluid filtered from the renal (kidney) glomerular capillaries into the Bowman's capsule per unit time.[3] Central to the physiologic maintenance of GFR is the differential basal tone of the afferent and efferent arterioles (see diagram). In other words, the filtration rate is dependent on the difference between the higher blood pressure created by vasoconstriction of the input or afferent arteriole versus the lower blood pressure created lesser vasoconstriction of the output or efferent arteriole. | 1 week, three months, six months, 12 months after kidney transplant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypothermic machine perfusion, Kidney Transplantation, Delayed graft function, perfusion pressure