Time of Ventilation and Lung Function of Ventilated Patients Under Therapy With Dornase Alfa
NCT ID: NCT00204685
Last Updated: 2006-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
540 participants
INTERVENTIONAL
2003-08-31
2006-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Interventions
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dornase alfa
Eligibility Criteria
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Inclusion Criteria
* mechanical ventilation
* expected ventilation time 3 days or longer
* full therapy is possible
* expectet ventilation time not longer than 21 days
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Joachim Riethmueller, Dr. med.
UNKNOWN
University Hospital Tuebingen
OTHER
Principal Investigators
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Joachim Riethmueller, Dr. med.
Role: STUDY_DIRECTOR
University Children's Hospital Tuebingen
Locations
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University Hospital, Anaesthesiology
Tübingen, Baden-Wurttemberg, Germany
Charité, Universitätsmedizin Berlin, Campus Mitte, Innere Intensivstation
Berlin, , Germany
Universität Charité, Campus Mitte, Anästhesie, Intensivstation
Berlin, , Germany
Vivantes Klinikum Spandau, Klinik für Anästhesie
Berlin, , Germany
Klinikum Chemnitz gGmbH, Innere Medizin
Chemnitz, , Germany
Universitätsklinikum Erlangen Medizinische Klinik, Intensivstation I
Erlangen, , Germany
Universitätsklinikum, Innere Medizin, Intensivstation
Frankfurt, , Germany
Universitätsklinikum Hamburg-Eppendorf, Medizinische Intensivstation
Hamburg, , Germany
Medizinische Hochschule Hannover, Anästhesiologie
Hanover, , Germany
Anästhesiolog. Klinik der Ruprecht-Karls-Universität
Heidelberg, , Germany
Universitätsklinikum des Saarlandes, Innere Medizin III, Internistische Intensivstation
Homburg / Saar, , Germany
Klinik für Anästhesiologie u. IntensivtherapieUniversität Leipzig
Leipzig, , Germany
Universitätsklinik Lübeck, Medizinische Klinik 1
Lübeck, , Germany
Department of internal Medicine
Lüdenscheid, , Germany
Universität Magdeburg, Innere Medizin,
Magdeburg, , Germany
Gutenberg-Universität, Anästhesie-Intensivstation
Mainz, , Germany
Johannes Gutenberg-Universität Mainz, II. Medizinische Klinik, Intensivstation
Mainz, , Germany
Johannes-Gutenberg-Universität, Neurochirurgische Klinik
Mainz, , Germany
Universitätsklinikum Mannheim, I. Med. Klinik
Mannheim, , Germany
Klinikum der Philipps-Universität Marburg, Intensivstation III
Marburg, , Germany
Klinikum der Univ. München Großhadern, Anaesthesiologische Intensivstation
München, , Germany
Klinikum der Univ. München Großhadern
München, , Germany
Ludwig Maximilians Universität München, Großhadern, Neurologie-Intensiv
München, , Germany
Berufsgenossenschaftliche Klinik Tuebingen, Intensive care Unit
Tübingen, , Germany
Intensive Care Unit of the Internal Department, Universitiy of Tuebingen
Tübingen, , Germany
Countries
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References
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Touleimat BA, Conoscenti CS, Fine JM. Recombinant human DNase in management of lobar atelectasis due to retained secretions. Thorax. 1995 Dec;50(12):1319-21; discussion 1323. doi: 10.1136/thx.50.12.1319.
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Shah PL, Scott SF, Knight RA, Marriott C, Ranasinha C, Hodson ME. In vivo effects of recombinant human DNase I on sputum in patients with cystic fibrosis. Thorax. 1996 Feb;51(2):119-25. doi: 10.1136/thx.51.2.119.
Shah PL, Hodson ME. New treatment strategies in cystic fibrosis: rhDNase. Monaldi Arch Chest Dis. 1996 Apr;51(2):125-9.
Bates RD, Nahata MC. Aerosolized dornase alpha (rhDNase) in cystic fibrosis. J Clin Pharm Ther. 1995 Dec;20(6):313-5. doi: 10.1111/j.1365-2710.1995.tb00703.x.
Reiter PD, Townsend SF, Velasquez R. Dornase alfa in premature infants with severe respiratory distress and early bronchopulmonary dysplasia. J Perinatol. 2000 Dec;20(8 Pt 1):530-4. doi: 10.1038/sj.jp.7200456. No abstract available.
Durward A, Forte V, Shemie SD. Resolution of mucus plugging and atelectasis after intratracheal rhDNase therapy in a mechanically ventilated child with refractory status asthmaticus. Crit Care Med. 2000 Feb;28(2):560-2. doi: 10.1097/00003246-200002000-00045.
Shah PL, Conway S, Scott SF, Rainisio M, Wildman M, Stableforth D, Hodson ME. A case-controlled study with dornase alfa to evaluate impact on disease progression over a 4-year period. Respiration. 2001;68(2):160-4. doi: 10.1159/000050486.
Fuchs HJ, Borowitz DS, Christiansen DH, Morris EM, Nash ML, Ramsey BW, Rosenstein BJ, Smith AL, Wohl ME. Effect of aerosolized recombinant human DNase on exacerbations of respiratory symptoms and on pulmonary function in patients with cystic fibrosis. The Pulmozyme Study Group. N Engl J Med. 1994 Sep 8;331(10):637-42. doi: 10.1056/NEJM199409083311003.
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Brandt T, Breitenstein S, von der Hardt H, Tummler B. DNA concentration and length in sputum of patients with cystic fibrosis during inhalation with recombinant human DNase. Thorax. 1995 Aug;50(8):880-2. doi: 10.1136/thx.50.8.880.
Grassme H, Kirschnek S, Riethmueller J, Riehle A, von Kurthy G, Lang F, Weller M, Gulbins E. CD95/CD95 ligand interactions on epithelial cells in host defense to Pseudomonas aeruginosa. Science. 2000 Oct 20;290(5491):527-30. doi: 10.1126/science.290.5491.527.
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
Cook DJ, Walter SD, Cook RJ, Griffith LE, Guyatt GH, Leasa D, Jaeschke RZ, Brun-Buisson C. Incidence of and risk factors for ventilator-associated pneumonia in critically ill patients. Ann Intern Med. 1998 Sep 15;129(6):433-40. doi: 10.7326/0003-4819-129-6-199809150-00002.
Other Identifiers
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LUFIT
Identifier Type: -
Identifier Source: org_study_id