The Potential Role of Efficacy and Safety Evaluation of N-Acetylcysteine Administration During Liver Procurement. The NAC-400 Single Center Randomized Controlled Trial.

Autor:	Gómez-Gavara C; Department of HPB Surgery and Transplants, Vall d'Hebron University Hospital, Barcelona, Spain., Moya-Herraiz Á; Department of HPB Surgery, Castellon General Hospital, CEU Cardenal Herrera University, Alfara del Patriarca, Spain., Hervás D; Statistics Unit, La Fe University Hospital, Valencia, Spain., Pérez-Rojas J; Pathological Anatomy Department, La Fe University Hospital, Valencia, Spain., LaHoz A; Biomarkers and Precision Medicine Unit, IIS La Fe, Valencia, Spain., López-Andújar R; HPB Surgery and Transplant Unit, La Fe University Hospital, Valencia, Spain.
Jazyk:	angličtina
Zdroj:	Transplantation [Transplantation] 2021 Oct 01; Vol. 105 (10), pp. 2245-2254.
DOI:	10.1097/TP.0000000000003487
Abstrakt:	Background: N-acetylcysteine infusions have been widely used to reduce ischemia/reperfusion damage to the liver; however, convincing evidence of their benefits is lacking. Objective: To perform the largest randomized controlled trial to compare the impact of N-acetylcysteine infusion during liver procurement on liver transplant outcomes. Methods: Single center, randomized trial with patients recruited from La Fe University Hospital, Spain, from February 2012 to January 2016. A total of 214 grafts were transplanted and randomized to the N-acetylcysteine group (n = 113) or to the standard protocol without N-acetylcysteine (n = 101). The primary endpoint was allograft dysfunction (Olthoff criteria). Secondary outcomes included metabolomic biomarkers of oxidative stress levels, interactions between cold ischemia time and alanine aminotransferase level and graft and patient survival (ID no. NCT01866644). Results: The incidence of primary dysfunction was 34% (31% in the N-acetylcysteine group and 37.4% in the control group [P = 0.38]). N-acetylcysteine administration reduced the alanine aminotransferase level when cold ischemia time was longer than 6 h (P = 0.0125). Oxidative metabolites (glutathione/oxidized glutathione and ophthalmic acid) were similar in both groups (P > 0.05). Graft and patient survival rates at 12 mo and 3 y were similar between groups (P = 0.54 and P = 0.69, respectively). Conclusions: N-acetylcysteine administration during liver procurement does not improve early allograft dysfunction according to the Olthoff classification. However, when cold ischemia time is longer than 6 h, N-acetylcysteine improves postoperative ALT levels. Competing Interests: The authors declare no funding or conflicts of interest. (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)
Databáze:	MEDLINE
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