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Hypothermic Oxygenated Machine Perfusion of Extended Criteria Kidney Allografts From Brain Death Donors

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ClinicalTrials.gov Identifier: NCT03378817
Recruitment Status : Recruiting
First Posted : December 20, 2017
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Georg Lurje, M.D., University Hospital, Aachen

Brief Summary:
Kidney transplantation (KT) has emerged as the mainstay of treatment for end-stage kidney disease. In an effort to address the widening gap between demand and supply of donor organs, there has been an increase in the numbers of "marginal" or functionally impaired renal allografts that had to be accepted for KT over the decades. The use of extended criteria donor (ECD) allografts is associated with a higher incidence of primary graft non-function (PNF) and/or delayed graft function (DGF). Hypothermic oxygenated machine perfusion (HOPE) has been successfully tested in pre-clinical experiments and in a few clinical series of donation after cardiac death (DCD) in liver transplantation. The present trial is an investigator-initiated pilot study on the effects of HOPE on ECD-allografts in donation after brain death (DBD) KT. Fifteen kidney allografts will be submitted to 2 hours of HOPE before implantation and are going to be compared to a case matched group transplanted after conventional cold storage (CCS).

Condition or disease Intervention/treatment Phase
Reperfusion Injury Hypothermic Oxygenated Machine Perfusion Procedure: HOPE Other: Conventional cold storage Not Applicable

Detailed Description:
The present trial is an investigator-initiated pilot study on the effects of HOPE on ECD-allografts in DBD KT. Fifteen kidney allografts with defined inclusion/exclusion criteria will be submitted to 2 hours of HOPE via the renal artery before implantation and are going to be compared to a case matched group of 30 patients (1:2 matching) transplanted after CCS. Besides the clinical evaluation of HOPE-"reconditioned" allograft function, a targeted biomarker analysis is planned using tissue, serum, and urine samples as the translational and basic research aspect of the present study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pilot study, case matched (1:2)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hypothermic Oxygenated Machine Perfusion of Extended Criteria Kidney Allografts From Brain Death Donors - a Prospective Cohort Study
Actual Study Start Date : December 5, 2017
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
Active Comparator: Conventional cold storage
Conventional static cold storage (CCS) on temperature 0-4 °C from organ procurement (historical case matched group)
Other: Conventional cold storage
No intervention

Experimental: Hypothermic oxygenated perfusion (HOPE)
HOPE for 2 hours via the renal artery in a recirculating and pressure controlled system, Belzer (UW) machine perfusion solution, perfusate temperature 0-4 °C, perfusate oxygenation pO2 of 60-80 kPa Other Name: Hypothermic machine perfusion (HMP)
Procedure: HOPE
HOPE for 2 hours via the renal artery in a recirculating and pressure controlled system, Belzer (UW) machine perfusion solution, perfusate temperature 0-4 °C, perfusate oxygenation pO2 of 60-80 kPa Other Name: Hypothermic machine perfusion (HMP)




Primary Outcome Measures :
  1. EGF [ Time Frame: 7. postoperative day ]
    1. Early graft function (EGF) (assessed by serum creatinine, urea and potassium)


Secondary Outcome Measures :
  1. DGF [ Time Frame: 7 days post-transplant ]
    DGF (defined as the need for dialysis in the first 7-days post-transplantation)

  2. fDGF [ Time Frame: 7 days post-transplant ]
    Functional DGF (fDGF) defined as <10% fall in serum creatinine for 3 consecutive days in the first week post-transplantation)

  3. CRR2, CRR5 [ Time Frame: 5 days post-transplant ]
    Creatinine reduction ratio day 2 (CRR2= creatinine day 1−creatinine day 2/creatinine day 1) and CRR5 (CRR5=pre-transplant creatinine−creatinine day 5/pre-transplant creatinine)

  4. postoperative complications [ Time Frame: Subjects will be followed 6 months postoperatively ]
    Clavien-Dindo complication score

  5. Cumulative postoperative complications [ Time Frame: Subjects will be followed 6 months postoperatively ]
    Comprehensive complication index (CCI)

  6. Duration of intensive care stay [ Time Frame: Subjects will be followed 6 months postoperatively ]
    Duration of ICU stay

  7. Duration of hospital stay [ Time Frame: Subjects will be followed 6 months postoperatively ]
    Duration of hospitalisation

  8. Graft survival [ Time Frame: Subjects will be followed 6 months postoperatively ]
    Six months graft survival

  9. Renal function [ Time Frame: Subjects will be followed 6 months postoperatively ]
    Renal function (serum creatinine and estimated glomerular filtration rate (eGFR))

  10. Ischemia-reperfusion injury [ Time Frame: Before HOPE, after Kidney implantation (0-2 hrs) ]
    Kidney samples taken upon arrival of the organ (before HOPE), and at the end of the implantation procedure before closure of the abdomen



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Dialysis-requiring Patients, suffering from end stage kidney disease, listed for KT and receiving ECD organs at the Department of Surgery and Transplantation, University Hospital RWTH Aachen, Aachen, Germany. Informed consent is obtained from all subjects participating in the trial by a qualified member of the study team.

ECD is defined as followed: deceased donors > 60 years and older, and those aged between 50-59 years with at least two of the following conditions: cerebrovascular cause of death, serum Creatinine greater than 1.5 mg/dL (132.6 µmol/L), history of arterial hypertension

Exclusion Criteria:

  1. Recipients of living donor kidney transplants
  2. Previous kidney transplantation
  3. Participation in other kidney related trials
  4. The subject received an investigational drug within 30 days prior to inclusion
  5. The subject is unwilling or unable to follow the procedures outlined in the protocol
  6. The subject is mentally or legally incapacitated
  7. Non-German or non-English speakers
  8. Family members of the investigators or employees of the participating department
  9. The subject is mentally or legally incapacitated
  10. The subject suffers from uncontrolled bacterial or viral infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03378817


Contacts
Contact: Zoltan Czigany, M.D. +492418037823 glurje@ukaachen.de
Contact: Franziska A. Meister, M.D. +492418037321 fmeister@ukaachen.de

Locations
Germany
Department of Surgery and Transplantation, University Hospital RWTH Aachen Recruiting
Aachen, Germany, 52074
Contact: Georg Lurje, M.D.    +492418035048    glurje@ukaachen.de   
Sponsors and Collaborators
University Hospital, Aachen
Investigators
Principal Investigator: Georg Lurje, M.D. RWTH Aachen University

Responsible Party: Georg Lurje, M.D., Attending Transplant Surgeon, University Hospital, Aachen
ClinicalTrials.gov Identifier: NCT03378817     History of Changes
Other Study ID Numbers: EK 184-17
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Georg Lurje, M.D., University Hospital, Aachen:
Extended criteria donor
Donation after brain death
HOPE
Kidney transplantation

Additional relevant MeSH terms:
Hypothermia
Reperfusion Injury
Brain Death
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Death
Body Temperature Changes
Signs and Symptoms