Status:
UNKNOWN
Time of Ventilation and Lung Function of Ventilated Patients Under Therapy With Dornase Alfa
Lead Sponsor:
University Hospital Tuebingen
Collaborating Sponsors:
Joachim Riethmueller, Dr. med.
Conditions:
Long Term Ventilation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine whether Inhalation of Recombinant Human Deoxyribonuclease Shortens Ventilation Time in Mechanically Ventilated Adults
Detailed Description
Recombinant human deoxyribonuclease I (rhDNase, dornase alpha), administered by inhalation, is currently used as a mucolytic agent in the treatment of cystic fibrosis. This prospective, randomized, pl...
Eligibility Criteria
Inclusion
- adult
- mechanical ventilation
- expected ventilation time 3 days or longer
- full therapy is possible
- expectet ventilation time not longer than 21 days
Exclusion
- medicinal point of view: patient won´t survive the next 21 days
- concomitant pneumococcal disease (like tuberculosis, carcinoma)
- endotracheal bleeding
- pneumothorax with no relief (e.g. thoracic drainage)
- pregnancy
- breast feeding
- participation in another clinical trail
- mechanical ventilation since more than 48 hours
- mechanical ventilation on the basis of another reason than operation, trauma or pulmonary decompensation
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT00204685
Start Date
August 1 2003
End Date
July 1 2006
Last Update
September 14 2006
Active Locations (25)
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1
University Hospital, Anaesthesiology
Tübingen, Baden-Wurttemberg, Germany, 72076
2
Charité, Universitätsmedizin Berlin, Campus Mitte, Innere Intensivstation
Berlin, Germany, 10117
3
Universität Charité, Campus Mitte, Anästhesie, Intensivstation
Berlin, Germany, 10117
4
Vivantes Klinikum Spandau, Klinik für Anästhesie
Berlin, Germany, 13585