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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

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:

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

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

NCT ID

NCT03378817

First Posted

December 8, 2017

Last Updated

April 3, 2020

Sponsor

University Hospital, Aachen

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

Studies a U.S. FDA-regulated Device Product

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

Intervention Type

Procedure

Intervention Name(s)

HOPE

Intervention Description

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