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

Reperfusion Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03378817
• Other study ID #: EK 184-17
• Status: Completed
• Phase: N/A
• Start date: December 5, 2017
• Est. completion date: March 30, 2020

Study information

• Verified date: April 2020
• Source: University Hospital, Aachen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 30, 2020
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Death
• Hypothermia
• Hypothermic Oxygenated Machine Perfusion
• Reperfusion Injury

Intervention

Procedure:
• HOPE
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)

Other:
• Conventional cold storage
No intervention

Locations

Country	Name	City	State
Germany	Department of Surgery and Transplantation, University Hospital RWTH Aachen	Aachen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Aachen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DGF	DGF (defined as the need for dialysis in the first 7-days post-transplantation)	7 days post-transplant
Secondary	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)	5 days post-transplant
Secondary	postoperative complications	Clavien-Dindo complication score	Subjects will be followed 6 months postoperatively
Secondary	Cumulative postoperative complications	Comprehensive complication index (CCI)	Subjects will be followed 6 months postoperatively
Secondary	Duration of intensive care stay	Duration of ICU stay	Subjects will be followed 6 months postoperatively
Secondary	Duration of hospital stay	Duration of hospitalisation	Subjects will be followed 6 months postoperatively
Secondary	Graft survival	Six months graft survival	Subjects will be followed 6 months postoperatively
Secondary	Renal function	Renal function (serum creatinine and estimated glomerular filtration rate (eGFR))	Subjects will be followed 6 months postoperatively
Secondary	Perfusion Parameter	Flow and thus renal resistance	During HOPE