Double-blind placebo-controlled randomized trial of N -acetylcysteine infusion following live donor liver transplantatio
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ORIGINAL ARTICLE
Double‑blind placebo‑controlled randomized trial of N‑acetylcysteine infusion following live donor liver transplantation Mohammed Abdullatheef Thirunavayakalathil1 · Christi Titus Varghese1,2 · Viju Kumar Bharathan1 · Biju Chandran1 · Krishnanunni Nair1 · Shweta Mallick1 · Johns Shaji Mathew1 · Binoj Sivasankara Pillai Thankamony Amma1 · Ramachandran Narayana Menon1 · Unnikrishnan Gopalakrishnan1 · Dinesh Balakrishnan1 · Othiyil Vayoth Sudheer · Sudhindran Surendran1 Received: 5 July 2020 / Accepted: 9 November 2020 © Asian Pacific Association for the Study of the Liver 2020
Abstract Background The role of N-acetylcysteine (NAC) in improving outcomes following live donor liver transplantation (LDLT) is not well established. We designed a randomized double-blind placebo-controlled trial to study the role of NAC infusion in recipients undergoing LDLT. Methods We assigned 150 patients who underwent LDLT by computer-generated random sequence on 1:1 ratio to either NAC group or placebo group. Patients in the NAC group received NAC infusion which was started at beginning of graft implantation at an initial loading dose of 150 mg/kg/h over 1 h, followed by 12.5 mg/kg/h for 4 h and then at 6.25 mg/kg/h continued for 91 h. Placebo group received normal saline. The primary endpoint was composite occurrence of acute kidney injury (AKI) and early allograft dysfunction (EAD) in the recipient. Secondary endpoints included levels of bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine, INR, primary graft non-function, intraoperative bleeding, post-transplant hospital stay and in-hospital mortality. Results The composite endpoint did not show any significant difference between the NAC and placebo group (21.3% vs 29.3%, p = 0.35). Peak AST (425.65 IU/L vs 702.24 IU/L, p = 0.02) and peak ALT (406.65 IU/L vs 677.99 IU/L, p = 0.01) levels were significantly lower in the study group. Time to normalization of transaminases was also significantly low in the study group. Conclusions Perioperative NAC infusion following LDLT resulted in significantly lower postoperative AST and ALT levels. Rapid normalization of transaminases was also observed. This, however, did not translate to improvement in AKI or EAD. Keywords Early allograft dysfunction · Liver enzymes · Acute kidney injury · Hepatic artery thrombosis · Primary nonfunction · Mortality · Postoperative bleeding · Post-transplant hospital stay · Renal replacement therapy · Hepatocyte injury Abbreviations AKI Acute kidney Injury ALF Acute liver failure ALT Alanine aminotransferase APOLT Auxiliary partial orthotopic liver transplantation ATP Adenosine triphosphate AST Aspartate aminotransferase DDLT Deceased donor liver transplantation EAD Early allograft dysfunction GRWR Graft-to-recipient weight ratio HAT Hepatic artery thrombosis * Christi Titus Varghese [email protected] Extended author information available on the last page of the article
HCC Hepatocellular carcinoma HTK Histidine tryptophan ketoglutarate H
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