POMP v0.1

• Research type

  Research Study

• Full title

  'In House' Pre-implantation Oxygenated Hypothermic Machine Perfusion Reconditioning after Cold Storage versus Cold Storage alone in ECD Kidneys from Brain Dead Donors

• IRAS ID

  147440

• Contact name

  Rutger Ploeg

• Contact email

  rutger.ploeg@nds.ox.ac.uk

• Sponsor organisation

  University of Oxford

• ISRCTN Number

  ISRCTN63852508

• Research summary

  Renal transplantation remains the therapy of choice for patients with end stage renal disease. However, the number of patients waiting for a kidney graft continues to increase and far exceeds the availability of donor grafts. A large number of deceased organ transplants manifest a degree of early dysfunction- delayed graft function(DGF). DGF has been shown to increase the incidence of chronic nephropathy and later graft loss.
  The shortage of donor organs has led the transplant community to accept an increasing number of older and more marginal donor grafts for transplantation. Kidneys from these donors are particularly vulnerable for the development of DGF and have decreased long term graft survival.
  One important modifiable risk factor of DGF is ischemia injury sustained during organ preservation. Optimizing the preservation of grafts during the preservation phase is essential to reduce this ischemic injury. In those older and more marginal donor kidneys, an optimized preservation is therefore of even greater importance.

  Previous studies have shown that placing a kidney onto a machine that pumps fluid around it (rather than storing in a box on ice as is standard practice) can reduce the incidence of DGF.
  Experimental studies in Pigs have shown that reconditioning marginal kidney by placing it on a machine with oxygen for a few hours before transplantation, after cold storage can improve outcomes.

  This study will compare cold storage with a brief period of hypothermic machine perfusion with oxygen once the kidney arrives at the transplant centre.
  Adult patients on the kidney transplant waiting list will be asked if they want to participate in this study, if they do consent, the kidney they will receive will be randomised to one of the above groups.
  The main outcome we are measuring is 1-year graft survival.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  14/SC/1072

• Date of REC Opinion

  11 Aug 2014

• REC opinion

  Further Information Favourable Opinion