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

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ClinicalTrials.gov Identifier: NCT00204685
Recruitment Status : Unknown
Verified September 2006 by University Hospital Tuebingen.
Recruitment status was:  Active, not recruiting
First Posted : September 20, 2005
Last Update Posted : September 14, 2006
Sponsor:
Collaborator:
Joachim Riethmueller, Dr. med.
Information provided by:
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

Condition or disease Intervention/treatment Phase
Long Term Ventilation Drug: dornase alfa Phase 2 Phase 3

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 Type : Interventional  (Clinical Trial)
Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Beatmungsdauer Und Lungenfunktion Bei Beatmeten Patienten Unter Therapie Mit Dornase Alfa - Randomisierte, Doppel-Blinde, Placebo-Kontrollierte, Multizentrische, Prospektive Klinische Studie
Study Start Date : August 2003
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Time of mechanical ventilation from beginning of the ventilation-therapy up to the end of the ventilation-therapy

Secondary Outcome Measures :
  1. reduction of atelectasis / dystelectasis
  2. improval of pulmonaryfunction
  3. reduction of pneumonia
  4. reduction of DNA concentrations in Airway Secretions
  5. length of stay at the Intensive Care Unit
  6. length of stay at the hospital


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00204685


Locations
Germany
University Hospital, Anaesthesiology
Tuebingen, Baden-Wuerttemberg, Germany, 72076
Charité, Universitätsmedizin Berlin, Campus Mitte, Innere Intensivstation
Berlin, Germany, 10117
Universität Charité, Campus Mitte, Anästhesie, Intensivstation
Berlin, Germany, 10117
Vivantes Klinikum Spandau, Klinik für Anästhesie
Berlin, Germany, 13585
Klinikum Chemnitz gGmbH, Innere Medizin
Chemnitz, Germany, 09113
Universitätsklinikum Erlangen Medizinische Klinik, Intensivstation I
Erlangen, Germany, 91054
Universitätsklinikum, Innere Medizin, Intensivstation
Frankfurt, Germany, 60590
Universitätsklinikum Hamburg-Eppendorf, Medizinische Intensivstation
Hamburg, Germany, 20246
Medizinische Hochschule Hannover, Anästhesiologie
Hannover, Germany, 30625
Anästhesiolog. Klinik der Ruprecht-Karls-Universität
Heidelberg, Germany, 69120
Universitätsklinikum des Saarlandes, Innere Medizin III, Internistische Intensivstation
Homburg / Saar, Germany, 66421
Klinik für Anästhesiologie u. IntensivtherapieUniversität Leipzig
Leipzig, Germany, 04103
Department of internal Medicine
Luedenscheid, Germany, 58505
Universitätsklinik Lübeck, Medizinische Klinik 1
Lübeck, Germany, 23538
Universität Magdeburg, Innere Medizin,
Magdeburg, Germany, 39120
Gutenberg-Universität, Anästhesie-Intensivstation
Mainz, Germany, 55131
Johannes Gutenberg-Universität Mainz, II. Medizinische Klinik, Intensivstation
Mainz, Germany, 55131
Johannes-Gutenberg-Universität, Neurochirurgische Klinik
Mainz, Germany, 55131
Universitätsklinikum Mannheim, I. Med. Klinik
Mannheim, Germany, 68167
Klinikum der Philipps-Universität Marburg, Intensivstation III
Marburg, Germany, 35033
Klinikum der Univ. München Großhadern, Anaesthesiologische Intensivstation
München, Germany, 81377
Klinikum der Univ. München Großhadern
München, Germany, 81377
Ludwig Maximilians Universität München, Großhadern, Neurologie-Intensiv
München, Germany, 81377
Berufsgenossenschaftliche Klinik Tuebingen, Intensive care Unit
Tuebingen, Germany, 72076
Intensive Care Unit of the Internal Department, Universitiy of Tuebingen
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Joachim Riethmueller, Dr. med.
Investigators
Study Director: Joachim Riethmueller, Dr. med. University Children’s Hospital Tuebingen

Publications:
Grassmé H, Kirschnek S, Riethmueller J, Riehle A, v Kürthy G, Lang F, Weller M, Gulbins E. Role of apoptosis in Pseudomonas aeruginosa pneumonia. Science 194, 11/2001: 1783a
24. Riethmueller J, Grassmé H, Ziebach R, Wessels J, Eyrich M, Stern M, Gulbins E. DNA-quantification and -qualification in sputum of CF-patients for monitoring rhDNase-therapy? Journal of Cystic Fibrosis 1. 6/2002: S110

ClinicalTrials.gov Identifier: NCT00204685     History of Changes
Other Study ID Numbers: LUFIT
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: September 14, 2006
Last Verified: September 2006