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

Primary Purpose

Reperfusion Injury, Hypothermic Oxygenated Machine Perfusion

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
HOPE
Conventional cold storage
Sponsored by
University Hospital, Aachen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reperfusion Injury focused on measuring Extended criteria donor, Donation after brain death, HOPE, Kidney transplantation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Surgery and Transplantation, University Hospital RWTH Aachen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional cold storage

Hypothermic oxygenated perfusion (HOPE)

Arm Description

Conventional static cold storage (CCS) on temperature 0-4 °C from organ procurement (historical case matched group)

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

CRR2, CRR5
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)
postoperative complications
Clavien-Dindo complication score
Cumulative postoperative complications
Comprehensive complication index (CCI)
Duration of intensive care stay
Duration of ICU stay
Duration of hospital stay
Duration of hospitalisation
Graft survival
Six months graft survival
Renal function
Renal function (serum creatinine and estimated glomerular filtration rate (eGFR))
Perfusion Parameter
Flow and thus renal resistance

Full Information

First Posted
December 8, 2017
Last Updated
April 3, 2020
Sponsor
University Hospital, Aachen
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1. Study Identification

Unique Protocol Identification Number
NCT03378817
Brief Title
Hypothermic Oxygenated Machine Perfusion of Extended Criteria Kidney Allografts From Brain Death Donors
Official Title
Hypothermic Oxygenated Machine Perfusion of Extended Criteria Kidney Allografts From Brain Death Donors - a Prospective Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 5, 2017 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Aachen

4. Oversight

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

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reperfusion Injury, Hypothermic Oxygenated Machine Perfusion
Keywords
Extended criteria donor, Donation after brain death, HOPE, Kidney transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot study, case matched (1:2)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional cold storage
Arm Type
Active Comparator
Arm Description
Conventional static cold storage (CCS) on temperature 0-4 °C from organ procurement (historical case matched group)
Arm Title
Hypothermic oxygenated perfusion (HOPE)
Arm Type
Experimental
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
HOPE
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Conventional cold storage
Intervention Description
No intervention
Primary Outcome Measure Information:
Title
DGF
Description
DGF (defined as the need for dialysis in the first 7-days post-transplantation)
Time Frame
7 days post-transplant
Secondary Outcome Measure Information:
Title
CRR2, CRR5
Description
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)
Time Frame
5 days post-transplant
Title
postoperative complications
Description
Clavien-Dindo complication score
Time Frame
Subjects will be followed 6 months postoperatively
Title
Cumulative postoperative complications
Description
Comprehensive complication index (CCI)
Time Frame
Subjects will be followed 6 months postoperatively
Title
Duration of intensive care stay
Description
Duration of ICU stay
Time Frame
Subjects will be followed 6 months postoperatively
Title
Duration of hospital stay
Description
Duration of hospitalisation
Time Frame
Subjects will be followed 6 months postoperatively
Title
Graft survival
Description
Six months graft survival
Time Frame
Subjects will be followed 6 months postoperatively
Title
Renal function
Description
Renal function (serum creatinine and estimated glomerular filtration rate (eGFR))
Time Frame
Subjects will be followed 6 months postoperatively
Title
Perfusion Parameter
Description
Flow and thus renal resistance
Time Frame
During HOPE

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg Lurje, M.D.
Organizational Affiliation
RWTH Aachen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery and Transplantation, University Hospital RWTH Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33082420
Citation
Meister FA, Czigany Z, Rietzler K, Miller H, Reichelt S, Liu WJ, Boecker J, Moeller MJ, Tolba RH, Hamesch K, Strnad P, Boor P, Stoppe C, Neumann UP, Lurje G. Decrease of renal resistance during hypothermic oxygenated machine perfusion is associated with early allograft function in extended criteria donation kidney transplantation. Sci Rep. 2020 Oct 20;10(1):17726. doi: 10.1038/s41598-020-74839-7.
Results Reference
derived
PubMed Identifier
31613224
Citation
Meister FA, Czigany Z, Bednarsch J, Bocker J, Amygdalos I, Morales Santana DA, Rietzler K, Moeller M, Tolba R, Boor P, Rohlfs W, Neumann UP, Lurje G. Hypothermic Oxygenated Machine Perfusion of Extended Criteria Kidney Allografts from Brain Dead Donors: Protocol for a Prospective Pilot Study. JMIR Res Protoc. 2019 Oct 14;8(10):e14622. doi: 10.2196/14622.
Results Reference
derived

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

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