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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)

Clemens Aigner, Alexis Slama, Maximilian Barta, Andreas Mitterbauer, György Lang, Shahrokh Taghavi, Jose Matilla, Roman Ullrich, Katharina Krenn, Peter Jaksch, Klaus Markstaller, Walter Klepetko
European Respiratory Journal 2015 46: OA3268; DOI: 10.1183/13993003.congress-2015.OA3268
Clemens Aigner
1Thoracic Surgery, Medical University of Vienna, Vienna, Austria
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Alexis Slama
1Thoracic Surgery, Medical University of Vienna, Vienna, Austria
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Maximilian Barta
1Thoracic Surgery, Medical University of Vienna, Vienna, Austria
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Andreas Mitterbauer
1Thoracic Surgery, Medical University of Vienna, Vienna, Austria
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György Lang
1Thoracic Surgery, Medical University of Vienna, Vienna, Austria
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Shahrokh Taghavi
1Thoracic Surgery, Medical University of Vienna, Vienna, Austria
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Jose Matilla
1Thoracic Surgery, Medical University of Vienna, Vienna, Austria
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Roman Ullrich
2Anaesthesia, Intensive Care and Pain Medicine, Medical University of Vienna, Vienna, Austria
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Katharina Krenn
2Anaesthesia, Intensive Care and Pain Medicine, Medical University of Vienna, Vienna, Austria
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Peter Jaksch
1Thoracic Surgery, Medical University of Vienna, Vienna, Austria
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Klaus Markstaller
2Anaesthesia, Intensive Care and Pain Medicine, Medical University of Vienna, Vienna, Austria
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Walter Klepetko
1Thoracic Surgery, Medical University of Vienna, Vienna, Austria
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Abstract

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.

  • Transplantation
  • Acute respiratory failure
  • Intensive care
  • Copyright ©ERS 2015
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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)
Clemens Aigner, Alexis Slama, Maximilian Barta, Andreas Mitterbauer, György Lang, Shahrokh Taghavi, Jose Matilla, Roman Ullrich, Katharina Krenn, Peter Jaksch, Klaus Markstaller, Walter Klepetko
European Respiratory Journal Sep 2015, 46 (suppl 59) OA3268; DOI: 10.1183/13993003.congress-2015.OA3268

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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)
Clemens Aigner, Alexis Slama, Maximilian Barta, Andreas Mitterbauer, György Lang, Shahrokh Taghavi, Jose Matilla, Roman Ullrich, Katharina Krenn, Peter Jaksch, Klaus Markstaller, Walter Klepetko
European Respiratory Journal Sep 2015, 46 (suppl 59) OA3268; DOI: 10.1183/13993003.congress-2015.OA3268
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More in this TOC Section

  • Differences in the lipidomic profile of bronchial washing (BW) and bronchoalveolar lavage (BAL) in lung transplanted patients
  • Diffusion capacity as a predictor of prognosis after onset of CLAD
  • Orthotopic lung transplantation in a single-mismatch-based mouse model shows signs of chronic lung allograft dyfunction (CLAD)
Show more 8.2 Transplantation

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