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Clinical Impact of Hypothermic Machine Perfusion in Renal Transplant Recipients (CIHMP)

Primary Purpose

Delayed Function of Renal Transplant

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Kidney Transporter machines
cold storage
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Delayed Function of Renal Transplant focused on measuring hypothermic machine perfusion, Kidney Transplantation, Delayed graft function, perfusion pressure

Eligibility Criteria

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

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

Sites / Locations

  • First Affiliated Hospital Xi'an Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

cold storage

Kidney Transporter machines

Arm 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. In machine perfusion group, patients will be analyzed by two subgroups based on pressure, resistance index and perfusion time duration.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 29, 2015
Last Updated
May 12, 2017
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborators
The First Hospital of Jilin University, 303rd Hospital of the People's Liberation Army, Fuzhou General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02621281
Brief Title
Clinical Impact of Hypothermic Machine Perfusion in Renal Transplant Recipients
Acronym
CIHMP
Official Title
Clinical Impact of Hypothermic Machine Perfusion in Renal Transplant Recipients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborators
The First Hospital of Jilin University, 303rd Hospital of the People's Liberation Army, Fuzhou General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Function of Renal Transplant
Keywords
hypothermic machine perfusion, Kidney Transplantation, Delayed graft function, perfusion pressure

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cold storage
Arm Type
Active Comparator
Arm 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. In machine perfusion group, patients will be analyzed by two subgroups based on pressure, resistance index and perfusion time duration.
Arm Title
Kidney Transporter machines
Arm Type
Active Comparator
Arm 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. In machine perfusion group, patients will be analyzed by two subgroups based on pressure, resistance index and perfusion time duration.
Intervention Type
Device
Intervention Name(s)
Kidney Transporter machines
Intervention Description
Kidney Transporter gently pumps the special cold solution through the kidney which outside the body.
Intervention Type
Device
Intervention Name(s)
cold storage
Intervention Description
The kidneys procurement from the donor will be cold stored using some cold preservation solution.
Primary Outcome Measure Information:
Title
The rate of Delayed graft function
Description
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.
Time Frame
the first week after transplant
Secondary Outcome Measure Information:
Title
Estimated Glomerular Filtration Rate
Description
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.
Time Frame
1 week, three months, six months, 12 months after kidney transplant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chenguang Ding, PhD
Phone
+8615091152077
Email
doctor_ding@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wujun Xue, PhD
Phone
+8613991990128
Email
xwujun@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wujun Xue, PhD
Organizational Affiliation
The First Affiliated Hospital of Xian Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chenguang Ding, PhD
Email
doctor_ding@126.com

12. IPD Sharing Statement

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Clinical Impact of Hypothermic Machine Perfusion in Renal Transplant Recipients

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