Clinical Trial: Study in Intensive Care Patients Regarding the Effect of Inhaled AP-301 After Primary Graft Dysfunction After Lung Transplantation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Pilot Study to Investigate the Clinical Effect of Orally Inhaled AP301 on Treatment of Primary Graft Dysfunction (PGD) in Mechanically Ventilated Patients After Primary Lu

Brief Summary: The purpose of this study is to investigate the effect of orally inhaled AP-301 on primary graft dysfunction after lung transplantation.

Detailed Summary:
Sponsor: Apeptico Forschung und Entwicklung GmbH

Current Primary Outcome: P/F ratio [ Time Frame: 7 days ]

The changes of the P/F ratio from T0 (time of PGD diagnosis) to day 7 of the treatment or to extubation of the patient


Original Primary Outcome: Same as current

Current Secondary Outcome: EVLW [ Time Frame: 7 days or until extubation ]

Measurement of extravascular lung water


Original Secondary Outcome: Same as current

Information By: Apeptico Forschung und Entwicklung GmbH

Dates:
Date Received: March 21, 2014
Date Started: June 2013
Date Completion:
Last Updated: July 23, 2015
Last Verified: July 2015