PT  - JOURNAL ARTICLE
AU  - Aigner, Clemens
AU  - Slama, Alexis
AU  - Barta, Maximilian
AU  - Mitterbauer, Andreas
AU  - Lang, György
AU  - Taghavi, Shahrokh
AU  - Matilla, Jose
AU  - Ullrich, Roman
AU  - Krenn, Katharina
AU  - Jaksch, Peter
AU  - Markstaller, Klaus
AU  - Klepetko, Walter
TI  - LATE-BREAKING ABSTRACT: Prospective randomised pilot study to investigate the clinical effect of orally inhaled AP301 on treatment of primary graft dysfunction (PGD) in patients after primary lung transplantation (LuTX)
AID  - 10.1183/13993003.congress-2015.OA3268
DP  - 2015 Sep 01
TA  - European Respiratory Journal
PG  - OA3268
VI  - 46
IP  - suppl 59
4099  - http://erj.ersjournals.com/content/46/suppl_59/OA3268.short
4100  - http://erj.ersjournals.com/content/46/suppl_59/OA3268.full
SO  - Eur Respir J2015 Sep 01; 46
AB  - Background: PGD following LuTX carries significant morbidity and mortality. AP301, an activator of ENaC-mediated Na(+) uptake represents a new concept for treatment of hyper-permeability oedema with promising preclinical results.Aims: This study aims to investigate the effect of AP301 on patients with PGD≥1 at ICU arrival after LuTX.Methods: Prospective randomised, placebo-controlled pilot-study. All patients fulfilling inclusion criteria are screened for PGD at ICU arrival. After randomization AP301 or placebo is administered via nebulizer twice daily for 7 days or until extubation. Otherwise patients are treated according to clinical routine protocol and followed for 30 days within the study.Results: From 7/2013-8/2014 20 patients were randomised 1:1 to AP301 (group 1) or placebo (group 2). Demographics were comparable in both groups as well as mean PaO2/FiO2 ratio at time of inclusion (236±91 vs 214±96). Patients in group 1 had a significantly shorter duration of intubation with 2±0,8 vs 3,7±2 days (p=0,02). There was a trend towards a shorter ICU stay (7,5±3,1 vs 10,8±8,7 days) and increased PaO2/FiO2 ratio in group 1 at 24h (313±126 vs 240±90), 48h (486±59 vs 460±33), 72h (504±40 vs 427±78) and 96h postoperative (549±0 vs 370±96). Thereafter no patient in group 1 was ventilated. 30-day survival was 100%.Conclusion: This pilot study showed impressive clinical effects of AP301 on patients with PGD after primary LuTX leading to a significantly shorter intubation time and a trend towards improved gas exchange and shorter ICU stay. Further investigation of AP301 for PGD treatment is warranted.