A randomized clinical trial testing the anti-inflammatory effects of pre-emptive inhaled nitric oxide in human liver transplantation
Lang JD, Smith AB, Brandon A, et al.PLoS ONE. 2014; 9: e86053.
Aims
To investigate inhaled nitric oxide (iNO) therapy on immediate graft function and post-transplant complications.
Interventions
Participants were randomised to receive iNO or placebo (nitrogen) during the operative phase of liver transplantation.
Participants
40 participants undergoing liver transplantation.
Outcomes
The study outcomes included percentage changes in aspartate aminotransferase, alanine aminotransferase, prothrombin time, alkaline phospatase and bilirubin, effects of iNO on surgical intensive care unit and hospital length of stay, post-operative hepatobiliary and all-cause complications, polymorphonuclear leukocytes accumulation and cell death.
Follow-up
9 months.
CET Conclusions
It is a little unclear what the true direction of this paper is. The title and results lean towards anti-inflammatory effects, but the sample size was based on a rather large expected difference in complication rates. Strangely the analysis of hepatobiliary complications is described as “post-hocâ€. The study has been adequately described and blinded, but frustratingly the results are presented split by centre, which makes it all the more confusing and reduces the power. The clinical question would have been better served to present the overall results across both centres clearly as the primary result. The finer points of the differences between centres and the impact this may have on the results should have then been discussed later as a secondary analysis.
Data analysis
Per protocol analysis
Quality notes
Previously assessed in Lang JD Jr, Teng X, Chumley P, Crawford JH, Isbell TS, et al. (2007) Inhaled NO accelerates restoration of liver function in adults following orthotopic liver transplantation. The Journal of clinical investigation 117: 2583–2591.
Trial registration
ClinicalTrials.gov – NCT00582010