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

NCT03378817 | Completed

• 1 other identifier: EK 184-17
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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).

Conditions

Reperfusion Injury; Hypothermic Oxygenated Machine Perfusion

Keywords

Extended criteria donor; Donation after brain death; HOPE; Kidney transplantation

Outcome Measures

Primary Outcomes (1)

• DGF

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

  7 days post-transplant

Secondary Outcomes (8)

• CRR2, CRR5

  5 days post-transplant

• postoperative complications

  Subjects will be followed 6 months postoperatively

• Cumulative postoperative complications

  Subjects will be followed 6 months postoperatively

• Duration of intensive care stay

  Subjects will be followed 6 months postoperatively

• Duration of hospital stay

  Subjects will be followed 6 months postoperatively

Study Arms (2)

Conventional cold storage

ACTIVE COMPARATOR

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

Other: Conventional cold storage

Hypothermic oxygenated perfusion (HOPE)

EXPERIMENTAL

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)

Procedure: HOPE

Interventions

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)

Hypothermic oxygenated perfusion (HOPE)

Conventional cold storage OTHER

No intervention

Conventional cold storage

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Recipients of living donor kidney transplants
• Previous kidney transplantation
• Participation in other kidney related trials
• 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

Sponsors & Collaborators

• University Hospital, Aachen: lead

Study Sites (1)

Department of Surgery and Transplantation, University Hospital RWTH Aachen

Aachen, 52074, Germany

Location

Related Publications (2)

• 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.

  PMID: 33082420 DERIVED

• 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.

  PMID: 31613224 DERIVED

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Georg Lurje, M.D.

  RWTH Aachen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Transplant Surgeon

Model Details: Pilot study, case matched (1:2)

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 20, 2017
• Study Start: December 5, 2017
• Primary Completion: September 30, 2019
• Study Completion: March 30, 2020
• Last Updated: April 7, 2020

Record last verified: 2020-04

Locations

DE (1)