Clinical trial NCT00204685: Time of Ventilation and Lung Function of Ventilated Patients Under Therapy With Dornase Alfa
Official title: Beatmungsdauer Und Lungenfunktion Bei Beatmeten Patienten Unter Therapie Mit Dornase Alfa - Randomisierte, Doppel-Blinde, Placebo-Kontrollierte, Multizentrische, Prospektive Klinische Studie
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Long Term Ventilation
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Joachim Riethmueller, Dr. med.
First posted: 2005-09-20
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Time of mechanical ventilation from beginning of the ventilation-therapy up to the end of the ventilation-therapy
Secondary outcomes:
measure: reduction of atelectasis / dystelectasis
measure: improval of pulmonaryfunction
measure: reduction of pneumonia
measure: reduction of DNA concentrations in Airway Secretions
measure: length of stay at the Intensive Care Unit
measure: length of stay at the hospital
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital, Anaesthesiology
state: Baden-Wuerttemberg
city: Berlin
country: Germany
facility: Charité, Universitätsmedizin Berlin, Campus Mitte, Innere Intensivstation
city: Berlin
country: Germany
facility: Universität Charité, Campus Mitte, Anästhesie, Intensivstation
city: Berlin
country: Germany
facility: Vivantes Klinikum Spandau, Klinik für Anästhesie
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH, Innere Medizin
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen Medizinische Klinik, Intensivstation I
city: Frankfurt
country: Germany
facility: Universitätsklinikum, Innere Medizin, Intensivstation
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf, Medizinische Intensivstation
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Anästhesiologie
city: Heidelberg
country: Germany
facility: Anästhesiolog. Klinik der Ruprecht-Karls-Universität
city: Homburg / Saar
country: Germany
facility: Universitätsklinikum des Saarlandes, Innere Medizin III, Internistische Intensivstation
city: Leipzig
country: Germany
facility: Klinik für Anästhesiologie u. IntensivtherapieUniversität Leipzig
city: Luedenscheid
country: Germany
facility: Department of internal Medicine
city: Lübeck
country: Germany
facility: Universitätsklinik Lübeck, Medizinische Klinik 1
city: Magdeburg
country: Germany
facility: Universität Magdeburg, Innere Medizin,
city: Mainz
country: Germany
facility: Gutenberg-Universität, Anästhesie-Intensivstation
city: Mainz
country: Germany
facility: Johannes Gutenberg-Universität Mainz, II. Medizinische Klinik, Intensivstation
city: Mainz
country: Germany
facility: Johannes-Gutenberg-Universität, Neurochirurgische Klinik
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim, I. Med. Klinik
city: Marburg
country: Germany
facility: Klinikum der Philipps-Universität Marburg, Intensivstation III
city: München
country: Germany
facility: Klinikum der Univ. München Großhadern, Anaesthesiologische Intensivstation
city: München
country: Germany
facility: Klinikum der Univ. München Großhadern
city: München
country: Germany
facility: Ludwig Maximilians Universität München, Großhadern, Neurologie-Intensiv
city: Tuebingen
country: Germany
facility: Berufsgenossenschaftliche Klinik Tuebingen, Intensive care Unit
city: Tuebingen
country: Germany
facility: Intensive Care Unit of the Internal Department, Universitiy of Tuebingen
Study officials:
affiliation: University Children's Hospital Tuebingen
name: Joachim Riethmueller, Dr. med.
role: STUDY_DIRECTOR
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