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Sponsors and Collaborators: |
University Hospital Tuebingen Joachim Riethmueller, Dr. med. |
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Information provided by: | University Hospital Tuebingen |
ClinicalTrials.gov Identifier: | NCT00204685 |
The purpose of this study is to determine whether Inhalation of Recombinant Human Deoxyribonuclease Shortens Ventilation Time in Mechanically Ventilated Adults
Condition | Intervention | Phase |
---|---|---|
Long Term Ventilation |
Drug: dornase alfa |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Beatmungsdauer Und Lungenfunktion Bei Beatmeten Patienten Unter Therapie Mit Dornase Alfa - Randomisierte, Doppel-Blinde, Placebo-Kontrollierte, Multizentrische, Prospektive Klinische Studie |
Estimated Enrollment: | 540 |
Study Start Date: | August 2003 |
Estimated Study Completion Date: | July 2006 |
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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Department of internal Medicine | |
Luedenscheid, Germany, 58505 | |
Intensive Care Unit of the Internal Department, Universitiy of Tuebingen | |
Tuebingen, Germany, 72076 | |
Berufsgenossenschaftliche Klinik Tuebingen, Intensive care Unit | |
Tuebingen, Germany, 72076 | |
Klinik für Anästhesiologie u. IntensivtherapieUniversität Leipzig | |
Leipzig, Germany, 04103 | |
Universitätsklinik Lübeck, Medizinische Klinik 1 | |
Lübeck, Germany, 23538 | |
Universitätsklinikum Mannheim, I. Med. Klinik | |
Mannheim, Germany, 68167 | |
Ludwig Maximilians Universität München, Großhadern, Neurologie-Intensiv | |
München, Germany, 81377 | |
Universität Magdeburg, Innere Medizin, | |
Magdeburg, Germany, 39120 | |
Universität Charité, Campus Mitte, Anästhesie, Intensivstation | |
Berlin, Germany, 10117 | |
Klinikum Chemnitz gGmbH, Innere Medizin | |
Chemnitz, Germany, 09113 | |
Klinikum der Philipps-Universität Marburg, Intensivstation III | |
Marburg, Germany, 35033 | |
Vivantes Klinikum Spandau, Klinik für Anästhesie | |
Berlin, Germany, 13585 | |
Universitätsklinikum, Innere Medizin, Intensivstation | |
Frankfurt, Germany, 60590 | |
Charité, Universitätsmedizin Berlin, Campus Mitte, Innere Intensivstation | |
Berlin, Germany, 10117 | |
Universitätsklinikum Erlangen Medizinische Klinik, Intensivstation I | |
Erlangen, Germany, 91054 | |
Johannes-Gutenberg-Universität, Neurochirurgische Klinik | |
Mainz, Germany, 55131 | |
Universitätsklinikum Hamburg-Eppendorf, Medizinische Intensivstation | |
Hamburg, Germany, 20246 | |
Klinikum der Univ. München Großhadern, Anaesthesiologische Intensivstation | |
München, Germany, 81377 | |
Klinikum der Univ. München Großhadern | |
München, Germany, 81377 | |
Johannes Gutenberg-Universität Mainz, II. Medizinische Klinik, Intensivstation | |
Mainz, Germany, 55131 | |
Universitätsklinikum des Saarlandes, Innere Medizin III, Internistische Intensivstation | |
Homburg / Saar, Germany, 66421 | |
Medizinische Hochschule Hannover, Anästhesiologie | |
Hannover, Germany, 30625 | |
Anästhesiolog. Klinik der Ruprecht-Karls-Universität | |
Heidelberg, Germany, 69120 | |
Gutenberg-Universität, Anästhesie-Intensivstation | |
Mainz, Germany, 55131 | |
Germany, Baden-Wuerttemberg | |
University Hospital, Anaesthesiology | |
Tuebingen, Baden-Wuerttemberg, Germany, 72076 |
Study Director: | Joachim Riethmueller, Dr. med. | University Children's Hospital Tuebingen |
Study ID Numbers: | LUFIT |
Study First Received: | September 9, 2005 |
Last Updated: | September 13, 2006 |
ClinicalTrials.gov Identifier: | NCT00204685 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |