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Steroid pretreatment of organ donors does not impact on early rejection and long‐term kidney allograft survival: Results from a multicenter randomized, controlled trial
Author(s) -
ReindlSchwaighofer Roman,
Kainz Alexander,
Jelencsics Kira,
Heinzel Andreas,
Berlakovich Gabriela,
Remport Ádám,
Heinze Georg,
Langer Robert,
Oberbauer Rainer
Publication year - 2019
Publication title -
american journal of transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.89
H-Index - 188
eISSN - 1600-6143
pISSN - 1600-6135
DOI - 10.1111/ajt.15252
Subject(s) - medicine , placebo , hazard ratio , multicenter trial , randomized controlled trial , urology , confidence interval , methylprednisolone , surgery , kidney transplantation , renal function , kidney , population , transplantation , gastroenterology , pathology , multicenter study , alternative medicine , environmental health
Steroid pretreatment of deceased donors reduces inflammation in allografts and is recommended by organ procurement guidelines. The impact on long‐term graft outcome, however, remains elusive. In this multicenter randomized controlled trial, 306 deceased donors providing organs for 455 renal transplant recipients were randomized to 1000 mg of methylprednisolone or placebo prior to organ procurement (ISRCTN78828338). The incidence of biopsy‐confirmed rejection (Banff>1) at 3 months was 23 (10%) in the steroid group and 26 (12%) in the placebo group ( P = .468). Five‐year functional graft survival was 84% and 82% for the steroid group and placebo group, respectively ( P ‐value = .941). The hazard ratio of functional graft loss was 0.90 (95% confidence interval 0.57‐1.42, P = .638) for steroid vs placebo in a multivariate Cox model. We did not observe effect modification by any of the predictors of graft survival and treatment modality. A robust sandwich estimate was used to account for paired grafts of some donors. The mean estimated GFR at 5 years was 47 mL/min per 1.73 m 2 in the steroid group and 48 mL/min per 1.73 m 2 in the placebo group ( P = .756). We conclude that steroid pretreatment does not impact on long‐term graft survival. In a donor population with higher risk of delayed graft function, however, repetitive and higher doses of steroid treatment may result in different findings.