Time of Ventilation and Lung Function of Ventilated Patients Under Therapy With Dornase Alfa

Launched by UNIVERSITY HOSPITAL TUEBINGEN · Sep 14, 2005

Keywords

ClinConnect Summary

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, placebo-controlled, double-blind clinical study should carry out whether the therapeutic use of rhDNase can be extended to adults who are undergoing long term ventilation at the intensive care. It is hypothesized that mechanically ventilated patients show elevated concentrations of DNA in airway secretions, and that these pathological DNA levels are reduced by rhDNase. The primary clinical goal o...

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Eligibility criteria

• Inclusion Criteria:
• • adult
• • mechanical ventilation
• • expected ventilation time 3 days or longer
• • full therapy is possible
• • expectet ventilation time not longer than 21 days
• Exclusion Criteria:
• • 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