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

University Hospital Tuebingen

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Long Term Ventilation

Treatments

Drug: dornase alfa

Study type

Interventional

Funder types

Other

Identifiers

NCT00204685

LUFIT

Details and patient eligibility

About

The purpose of this study is to determine whether Inhalation of Recombinant Human Deoxyribonuclease Shortens Ventilation Time in Mechanically Ventilated Adults

Full 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, 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 of the study is to establish wether ventilation times are shortend under inhalation of rhDNAse during the ventilation time. hDNase (verum) is compared with equal amounts of 0.9% saline solution (placebo).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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