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Heide A Stirnadel-Farrant,1 George Mu,2 Selin Cooper-Blenkinsopp,1 Rosemary O Schroyer,3 Kevin S Thorneloe,4 Ewen M Harrison,5 Susan MS Andrews6 1Department of WorldWide Epidemiology, GlaxoSmithKline, London, UK; 2Department of Data, Methods, and Analytics, GlaxoSmithKline, Collegeville, PA, USA; 3Department of Biostatistics, GlaxoSmithKline, Collegeville, PA, USA; 4Department of Translational Medicine, GlaxoSmithKline, Collegeville, PA, USA; 5Department of Centre for Medical Informatics, Usher Institute, University of Edinburgh, Edinburgh, UK; 6Department of Global Clinical Operations Development R&D, GlaxoSmithKline, Research Triangle Park, NC, USACorrespondence: Susan MS Andrews, Global Clinical Operations Development R&D GlaxoSmithKline Five Moore Drive, Research Triangle Park, NC, 27709-3398, USA, Tel +1-(919) 649-3944, Email susan.m.andrews@gsk.comPurpose: A variety of definitions for delayed graft function (DGF) have been proposed, but none has consistently been shown to be superior for predicting long-term graft outcomes for kidney donation after circulatory death (DCD) transplantation. In this study, real-world clinical outcome data following DCD transplantation were explored to determine the value of various DGF definitions for predicting graft survival.Patients and Methods: Data from 4 centers registered in the UK-based National Health Service Blood and Transplant registry (2010 to mid-2015) were used to assess 4 definitions of DGF in this retrospective chart review study.Results: Depending on the definition used, the frequency of DGF ranged from 119/362 (32.9%) when DGF was determined with available registry data and based on a requirement for dialysis within 7 days post-transplantation, to 224/315 (71.1%) when based on failure to achieve a 10% fall in serum creatinine (SCr) versus baseline per 24 hours averaged over the first 72 hours. Patients without clinical DGF as determined by a physician upon chart review, or when defined as < 30% reduction in baseline SCr within 7 days post-transplantation with or without dialysis, had significantly better graft survival probability 1 year (hazard ratio 2.08 and 4.48, respectively) and 5 years post-transplant, whereas serum creatinine level over the first 72 hours post-transplant was not predictive of graft survival at 1 year. Patients with clinical DGF upon physician chart review also had higher SCr, lower estimated glomerular filtration rate levels, and were dialyzed more (2.3 days) versus patients without (0.2 days).Conclusion: Delayed graft function, determined clinically or using a functional definition, is associated with poorer renal function and remains a useful predictor of graft survival at 1 year after DCD kidney transplantation.Keywords: delayed graft function, DGF, donation after circulatory death, DCD, serum creatinine, SCr |
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