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Title: A randomized clinical trial testing the anti-inflammatory effects of preemptive inhaled nitric oxide in human liver transplantation
Authors: John D. Lang
Alvin B. Smith
Angela Brandon
Kelley M. Bradley
Yuliang Liu
Wei Li
D. Ralph Crowe
Nirag C. Jhala
Richard C. Cross
Luc Frenette
Kenneth Martay
Youri L. Vater
Alexander A. Vitin
Gregory A. Dembo
Derek A. DuBay
J. Steven Bynon
Jeff M. Szychowski
Jorge D. Reyes
Jeffrey B. Halldorson
Stephen C. Rayhill
Andre A. Dick
Ramasamy Bakthavatsalam
Jared Brandenberger
Jo Ann Broeckel-Elrod
Laura Sissons-Ross
Terry Jordan
Lucinda Y. Chen
Arunotai Siriussawakul
Devin E. Eckhoff
Rakesh P. Patel
University of Washington School of Medicine
Jilin University
University of Alabama at Birmingham
Perelman School of Medicine
University of Texas Medical School at Houston
UC San Diego Health
Mahidol University
Keywords: Agricultural and Biological Sciences;Biochemistry, Genetics and Molecular Biology
Issue Date: 12-Feb-2014
Citation: PLoS ONE. Vol.9, No.2 (2014)
Abstract: Decreases in endothelial nitric oxide synthase derived nitric oxide (NO) production during liver transplantation promotes injury. We hypothesized that preemptive inhaled NO (iNO) would improve allograft function (primary) and reduce complications post-transplantation (secondary). Patients at two university centers (Center A and B) were randomized to receive placebo (n = 20/center) or iNO (80 ppm, n = 20/center) during the operative phase of liver transplantation. Data were analyzed at set intervals for up to 9-months post-transplantation and compared between groups. Patient characteristics and outcomes were examined with the Mann-Whitney U test, Student t-test, logistic regression, repeated measures ANOVA, and Cox proportional hazards models. Combined and site stratified analyses were performed. MELD scores were significantly higher at Center B (22.5 vs. 19.5, p<0.0001), surgical times were greater at Center B (7.7 vs. 4.5 hrs, p <0.001) and warm ischemia times were greater at Center B (95.4 vs. 69.7 min, p<0.0001). No adverse metabolic or hematologic effects from iNO occurred. iNO enhanced allograft function indexed by liver function tests (Center B, p<0.05; and p<0.03 for ALT with center data combined) and reduced complications at 9-months (Center A and B, p = 0.0062, OR = 0.15, 95% CI (0.04, 0.59)). ICU (p = 0.47) and hospital length of stay (p = 0.49) were not decreased. iNO increased concentrations of nitrate (p<0.001), nitrite (p<0.001) and nitrosylhemoglobin (p<0.001), with nitrite being postulated as a protective mechanism. Mean costs of iNO were $1,020 per transplant. iNO was safe and improved allograft function at one center and trended toward improving allograft function at the other. with registry number 00582010 and the following URL: © 2014 Lang et al.
ISSN: 19326203
Appears in Collections:Scopus 2011-2015

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