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

May 12, 2017 updated by: Ding,Chenguang, First Affiliated Hospital Xi'an Jiaotong University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • First Affiliated Hospital Xi'an Jiaotong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: cold storage
The kidneys procurement from the donor will be cold stored using some cold preservation solution.
Active Comparator: 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.
Device: Kidney Transporter machines
Kidney Transporter gently pumps the special cold solution through the kidney which outside the body.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of Delayed graft function
Time Frame: 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.
the first week after transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated Glomerular Filtration Rate
Time Frame: 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.
1 week, three months, six months, 12 months after kidney transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Collaborators

The First Hospital of Jilin University
Fuzhou General Hospital
303rd Hospital of the People's Liberation Army

Investigators

  • Principal Investigator: Wujun Xue, PhD, The First Affiliated Hospital of Xian Jiaotong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

November 29, 2015

First Submitted That Met QC Criteria

December 2, 2015

First Posted (Estimate)

December 3, 2015

Study Record Updates

Last Update Posted (Actual)

May 15, 2017

Last Update Submitted That Met QC Criteria

May 12, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LPT-G-1501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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