The effect of steroid pretreatment of deceased organ donors on liver allograft function: A blinded randomized placebo-controlled trial

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• 作者：Stefan Amatschek¹ ; ² ; ^&dagger ; ; Julia Wilflingseder¹ ; ² ; ^&dagger ; ; Mario Pones³ ; ^&dagger ; ; Alexander Kainz¹ ; ² ; Martin Bodingbauer³ ; Ferdinand Mü ; hlbacher³ ; Robert M. Langer⁴ ; Zsuzsanna Gerlei⁴ ; Rainer Oberbauer¹ ; ² ; ^{rainer.oberbauer@meduniwien.ac.at}
• 关键词：BCAR ; biopsy-confirmed rejection ; ALT ; alanine transaminase ; AST ; aspartate transaminase ; GGT ; glutamyl transpeptidase ; AP ; alkaline phosphatase ; RAI ; reaction activity index ; BIL ; total bilirubin ; ALB ; serum albumin
• 刊名：Journal of Hepatology
• 出版年：2012
• 期刊代码：162_01688278
• 类别：med
• 出版时间：June, 2012
• 卷：56
• 期：6
• 页码：1305-1309
• 文件大小：550 K

摘要

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Background & Aims

Brain death-associated inflammatory response contributes to increased risk of impaired early liver allograft function, which might be counterbalanced by steroid pretreatment of the organ donor. The aim of this randomized controlled trial was to elucidate whether steroid pretreatment of liver donors improves early liver allograft function, prevents rejection and prolongs survival.

Methods

A placebo-controlled blinded randomized clinical trial was performed in three different centers in Austria and Hungary between 2006 and 2008. Ninety deceased organ donors received either 1000 mg of methylprednisolone or placebo 6 h before recovery of organs. The primary end point was the concentration slope of transaminases within the first week. The secondary end point included survival and biopsy-confirmed acute rejection (BCAR) within 3 years after transplantation.

Results

Of the 90 randomized donors, 83 recipients were eligible for study. The trajectories of ALT and AST were not different between treatments (p = 0.40 and p = 0.13, respectively). Eight subjects died in the steroid and 13 in the placebo group within 3 years after engraftment (RR = 0.63 95%CI [0.29, 1.36], p = 0.31). Eleven recipients experienced biopsy-confirmed rejection (BCAR) in the steroid and 11 in the placebo group (RR = 1.02 95%CI [0.50, 2.10], p = 1.00). No effect modification could be identified in the predefined strata of donor age, sex, cold ischemic time, and cause of donor death.

Conclusions

Steroid pretreatment of organ donors did not improve outcomes after liver transplantation.