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NCT Number: NCT03378817

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

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).

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Key information

Conditions

Reperfusion Injury Cardiovascular Diseases Hypothermic Oxygenated Machine Perfusion Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery and Transplantation, University Hospital RWTH Aachen

Aachen, 52074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

HOPE

Procedure

HOPE for 1 hour 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)

Conventional cold storage

Other

No intervention

Primary outcomes

  1. DGF

    Time frame: 7 days post-transplant

    DGF (defined as the need for dialysis in the first 7-days post-transplantation)

Secondary outcomes

  1. 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)

  2. postoperative complications

    Time frame: Subjects will be followed 6 months postoperatively

    Clavien-Dindo complication score

  3. Cumulative postoperative complications

    Time frame: Subjects will be followed 6 months postoperatively

    Comprehensive complication index (CCI)

  4. Duration of intensive care stay

    Time frame: Subjects will be followed 6 months postoperatively

    Duration of ICU stay

  5. Duration of hospital stay

    Time frame: Subjects will be followed 6 months postoperatively

    Duration of hospitalisation

  6. Graft survival

    Time frame: Subjects will be followed 6 months postoperatively

    Six months graft survival

  7. Renal function

    Time frame: Subjects will be followed 6 months postoperatively

    Renal function (serum creatinine and estimated glomerular filtration rate (eGFR))

  8. Perfusion Parameter

    Time frame: During HOPE

    Flow and thus renal resistance

Sponsors and collaborators

Lead sponsor

University Hospital, Aachen

Other

Registry information

Official study title

Hypothermic Oxygenated Machine Perfusion of Extended Criteria Kidney Allografts From Brain Death Donors - a Prospective Cohort Study

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Dec 20, 2017
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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