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

Phase 2

• Conditions: Long Term Ventilation

• Registration Number: NCT00204685
• Lead Sponsor: University Hospital Tuebingen

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, 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).

Study Timeline

• Study Start: 2003-08
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-20
• Study Completion: 2006-07
• Status Verified: 2006-09
• Last Update Submitted: 2006-09-13
• Last Update Posted: 2006-09-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 540

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time of mechanical ventilation from beginning of the ventilation-therapy up to the end of the ventilation-therapy

Secondary Outcome Measures

Name	Time	Method
reduction of atelectasis / dystelectasis
improval of pulmonaryfunction
reduction of pneumonia
reduction of DNA concentrations in Airway Secretions
length of stay at the Intensive Care Unit
length of stay at the hospital

Trial Locations

Locations (25)

Charité, Universitätsmedizin Berlin, Campus Mitte, Innere Intensivstation; 🇩🇪 Berlin, Germany

Universität Charité, Campus Mitte, Anästhesie, Intensivstation; 🇩🇪 Berlin, Germany

Universitätsklinikum Erlangen Medizinische Klinik, Intensivstation I; 🇩🇪 Erlangen, Germany

Klinik für Anästhesiologie u. IntensivtherapieUniversität Leipzig; 🇩🇪 Leipzig, Germany

Universitätsklinikum des Saarlandes, Innere Medizin III, Internistische Intensivstation; 🇩🇪 Homburg / Saar, Germany

Universitätsklinik Lübeck, Medizinische Klinik 1; 🇩🇪 Lübeck, Germany

Johannes-Gutenberg-Universität, Neurochirurgische Klinik; 🇩🇪 Mainz, Germany

Klinikum der Univ. München Großhadern, Anaesthesiologische Intensivstation; 🇩🇪 München, Germany

Universitätsklinikum, Innere Medizin, Intensivstation; 🇩🇪 Frankfurt, Germany

Vivantes Klinikum Spandau, Klinik für Anästhesie; 🇩🇪 Berlin, Germany

Universitätsklinikum Hamburg-Eppendorf, Medizinische Intensivstation; 🇩🇪 Hamburg, Germany

Department of internal Medicine; 🇩🇪 Luedenscheid, Germany

Medizinische Hochschule Hannover, Anästhesiologie; 🇩🇪 Hannover, Germany

Anästhesiolog. Klinik der Ruprecht-Karls-Universität; 🇩🇪 Heidelberg, Germany

Universität Magdeburg, Innere Medizin,; 🇩🇪 Magdeburg, Germany

Klinikum der Philipps-Universität Marburg, Intensivstation III; 🇩🇪 Marburg, Germany

Intensive Care Unit of the Internal Department, Universitiy of Tuebingen; 🇩🇪 Tuebingen, Germany

Gutenberg-Universität, Anästhesie-Intensivstation; 🇩🇪 Mainz, Germany

Johannes Gutenberg-Universität Mainz, II. Medizinische Klinik, Intensivstation; 🇩🇪 Mainz, Germany

Universitätsklinikum Mannheim, I. Med. Klinik; 🇩🇪 Mannheim, Germany

Klinikum der Univ. München Großhadern; 🇩🇪 München, Germany

Ludwig Maximilians Universität München, Großhadern, Neurologie-Intensiv; 🇩🇪 München, Germany

Berufsgenossenschaftliche Klinik Tuebingen, Intensive care Unit; 🇩🇪 Tuebingen, Germany

Klinikum Chemnitz gGmbH, Innere Medizin; 🇩🇪 Chemnitz, Germany

University Hospital, Anaesthesiology; 🇩🇪 Tuebingen, Baden-Wuerttemberg, Germany