Clinical Impact of Hypothermic Machine Perfusion in Renal Transplant Recipients

Not Applicable

• Conditions: Delayed Function of Renal Transplant
• Interventions: Device: cold storage; Device: Kidney Transporter machines

• Registration Number: NCT02621281
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief 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.

Study Timeline

• Study First Submitted: 2015-11-29
• Study Start: 2015-12
• Study First Submitted QC: 2015-12-02
• Study First Posted: 2015-12-03
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-12
• Last Update Posted: 2017-05-15
• Primary Completion: 2018-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Donor

  1. Comply with the national DCD（donor after citizen death) guideline
  2. No high risk activities: such as history of drug abuse, history of intravenous drug use and risky sexual behavior
  3. No malignant melanoma, metastatic cancer, or incurable cancer; some of the early stages of cancer after a successful treatment can also be considered
  4. No active, untreated systemic bacterial, viral or fungal infection;
  5. Patients definitely identified
  6. Mechanical perfusion RI (resistance index ) [0.18, 0.50]

Recipient:

1. Age> = 16 years old, male or female
2. BMI<28
3. First Renal transplantation
4. Not in pregnancy or lactation, pregnancy test was negative, and promise not to be pregnant during treatment.
5. Before the clinical trial, Patient sign informed consent voluntarily

Exclusion Criteria

• Donor

  1. Older than 50 years old
  2. Serum HBV (hepatitis B virus), HCV (hepatitis C virus), HIV positive
  3. Donor kidney cold storage time over 30 hours
  4. Warm ischemia time over 20 minutes
  5. Other reagents are added perfusion for regulation of donor renal function

Recipient:

1. Double organ or multi-organ transplant
2. Blood type-incompatible
3. Patients with other malignant diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cold storage	cold storage	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.
Kidney Transporter machines	Kidney Transporter machines	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.

Primary Outcome Measures

Name	Time	Method
The rate of Delayed graft function	the first week after transplant	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.

Secondary Outcome Measures

Name	Time	Method
Estimated Glomerular Filtration Rate	1 week, three months, six months, 12 months after kidney transplant	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.

Trial Locations

Locations (1)

First Affiliated Hospital Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China