Hypothermic Oxygenated Perfusion for DCD Kidneys: A Multi-centre Trial
Research type
Research Study
Full title
Hypothermic oxygenated perfusion for DCD (Donation after Cardiac Death) kidney grafts: A multi-centre trial
IRAS ID
273420
Contact name
Adam Barlow
Contact email
Sponsor organisation
LEEDS TEACHING HOSPITALS NHS TRUST
ISRCTN Number
ISRCTN96735894
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Kidney transplantation remains the therapy of choice for patients with end stage kidney disease. However, the number of patients waiting for a kidneys continues to increase and far exceeds the availability of donors which has pushed transplant centres to consider less ideal organ donors. Such as donation after circulatory death (DCD) i.e. cardiac arrest, currently representing 45% of deceased donors in the UK and 20% in Switzerland.
Due to the inevitable delay between cardiac arrest and start of cold flush prior to procurement; DCD kidneys are more prone to develop delayed graft function (DGF) which is defined as the need for dialysis within the first 7 days after transplantation with rates as high as 55-60%.
To overcome these disadvantages of DCD organs, new concepts of organ preservation such as machine perfusion have been introduced. Machine perfusion has demonstrated superiority over conventional cold storage being associated with lower DGF and improved 1 and 3 year transplant kidney survival rate. The addition of Oxygen to cold machine perfusion is known to improve outcomes in liver transplantation and pre-clinical data suggests similar effects on transplanted kidneys. In this trial we aim to put different methods of DCD organ preservation in a comparison including oxygenated cold machine perfusion, simple cold machine perfusion and static cold storage to investigate any additional benefit of combining oxygenation and cold machine perfusion.
This study will take place across 2 sites; St. James’s University Hospital, Leeds and University Hospital, Zurich. It will involve 100 DCD kidney transplants and is expected to take 2 years. The participants will be consented and will require follow up over a period of 12 months post operatively including blood tests however this will not represent a deviation from the routine follow up protocol and the results will help shape the future of organ preservation.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
20/EM/0276
Date of REC Opinion
25 Feb 2021
REC opinion
Further Information Favourable Opinion