Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Joachim Riethmueller, Dr. med. | UNKNOWN |
The purpose of this study is to determine whether Inhalation of Recombinant Human Deoxyribonuclease Shortens Ventilation Time in Mechanically Ventilated Adults
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dornase alfa | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Time of mechanical ventilation from beginning of the ventilation-therapy up to the end of the ventilation-therapy |
| Measure | Description | Time Frame |
|---|---|---|
| reduction of atelectasis / dystelectasis | ||
| improval of pulmonaryfunction | ||
| reduction of pneumonia |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joachim Riethmueller, Dr. med. | University Children's Hospital Tuebingen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Anaesthesiology | Tübingen | Baden-Wurttemberg | 72076 | Germany | ||
| Charité, Universitätsmedizin Berlin, Campus Mitte, Innere Intensivstation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1548827 | Background | Aitken ML, Burke W, McDonald G, Shak S, Montgomery AB, Smith A. Recombinant human DNase inhalation in normal subjects and patients with cystic fibrosis. A phase 1 study. JAMA. 1992 Apr 8;267(14):1947-51. | |
| 9773909 | Background | Harms HK, Matouk E, Tournier G, von der Hardt H, Weller PH, Romano L, Heijerman HG, FitzGerald MX, Richard D, Strandvik B, Kolbe J, Kraemer R, Michalsen H. Multicenter, open-label study of recombinant human DNase in cystic fibrosis patients with moderate lung disease. DNase International Study Group. Pediatr Pulmonol. 1998 Sep;26(3):155-61. doi: 10.1002/(sici)1099-0496(199809)26:33.0.co;2-k. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| reduction of DNA concentrations in Airway Secretions |
| length of stay at the Intensive Care Unit |
| length of stay at the hospital |
| Berlin |
| 10117 |
| Germany |
| Universität Charité, Campus Mitte, Anästhesie, Intensivstation | Berlin | 10117 | Germany |
| Vivantes Klinikum Spandau, Klinik für Anästhesie | Berlin | 13585 | Germany |
| Klinikum Chemnitz gGmbH, Innere Medizin | Chemnitz | 09113 | Germany |
| Universitätsklinikum Erlangen Medizinische Klinik, Intensivstation I | Erlangen | 91054 | Germany |
| Universitätsklinikum, Innere Medizin, Intensivstation | Frankfurt | 60590 | Germany |
| Universitätsklinikum Hamburg-Eppendorf, Medizinische Intensivstation | Hamburg | 20246 | Germany |
| Medizinische Hochschule Hannover, Anästhesiologie | Hanover | 30625 | Germany |
| Anästhesiolog. Klinik der Ruprecht-Karls-Universität | Heidelberg | 69120 | Germany |
| Universitätsklinikum des Saarlandes, Innere Medizin III, Internistische Intensivstation | Homburg / Saar | 66421 | Germany |
| Klinik für Anästhesiologie u. IntensivtherapieUniversität Leipzig | Leipzig | 04103 | Germany |
| Universitätsklinik Lübeck, Medizinische Klinik 1 | Lübeck | 23538 | Germany |
| Department of internal Medicine | Lüdenscheid | 58505 | Germany |
| Universität Magdeburg, Innere Medizin, | Magdeburg | 39120 | Germany |
| Gutenberg-Universität, Anästhesie-Intensivstation | Mainz | 55131 | Germany |
| Johannes Gutenberg-Universität Mainz, II. Medizinische Klinik, Intensivstation | Mainz | 55131 | Germany |
| Johannes-Gutenberg-Universität, Neurochirurgische Klinik | Mainz | 55131 | Germany |
| Universitätsklinikum Mannheim, I. Med. Klinik | Mannheim | 68167 | Germany |
| Klinikum der Philipps-Universität Marburg, Intensivstation III | Marburg | 35033 | Germany |
| Klinikum der Univ. München Großhadern, Anaesthesiologische Intensivstation | München | 81377 | Germany |
| Klinikum der Univ. München Großhadern | München | 81377 | Germany |
| Ludwig Maximilians Universität München, Großhadern, Neurologie-Intensiv | München | 81377 | Germany |
| Berufsgenossenschaftliche Klinik Tuebingen, Intensive care Unit | Tübingen | 72076 | Germany |
| Intensive Care Unit of the Internal Department, Universitiy of Tuebingen | Tübingen | 72076 | Germany |
| 9230743 | Background | King M, Dasgupta B, Tomkiewicz RP, Brown NE. Rheology of cystic fibrosis sputum after in vitro treatment with hypertonic saline alone and in combination with recombinant human deoxyribonuclease I. Am J Respir Crit Care Med. 1997 Jul;156(1):173-7. doi: 10.1164/ajrccm.156.1.9512074. |
| 8947060 | Background | Rochat T, Pastore FD, Schlegel-Haueter SE, Filthuth I, Auckenthaler R, Belli D, Suter S. Aerosolized rhDNase in cystic fibrosis: effect on leucocyte proteases in sputum. Eur Respir J. 1996 Nov;9(11):2200-6. doi: 10.1183/09031936.96.09112200. |
| 8893254 | Background | Dasgupta B, King M. Reduction in viscoelasticity in cystic fibrosis sputum in vitro using combined treatment with nacystelyn and rhDNase. Pediatr Pulmonol. 1996 Sep;22(3):161-6. doi: 10.1002/(SICI)1099-0496(199609)22:33.0.CO;2-S. |
| 8726943 | Background | Puchelle E, Zahm JM, de Bentzmann S, Grosskopf C, Shak S, Mougel D, Polu JM. Effects of rhDNase on purulent airway secretions in chronic bronchitis. Eur Respir J. 1996 Apr;9(4):765-9. doi: 10.1183/09031936.96.09040769. |
| 8903903 | Background | Desai M, Weller PH, Spencer DA. Clinical benefit from nebulized human recombinant DNase in Kartagener's syndrome. Pediatr Pulmonol. 1995 Nov;20(5):307-8. doi: 10.1002/ppul.1950200509. |
| 8553310 | Background | 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. |
| 8756815 | Background | Wills PJ, Wodehouse T, Corkery K, Mallon K, Wilson R, Cole PJ. Short-term recombinant human DNase in bronchiectasis. Effect on clinical state and in vitro sputum transportability. Am J Respir Crit Care Med. 1996 Aug;154(2 Pt 1):413-7. doi: 10.1164/ajrccm.154.2.8756815. |
| 9727769 | Background | Boeuf B, Prouix F, Morneau S, Marton D, Lacroix J. Safety of endotracheal rh DNAse (Pulmozyme) for treatment of pulmonary atelectasis in mechanically ventilated children. Pediatr Pulmonol. 1998 Aug;26(2):147. doi: 10.1002/(sici)1099-0496(199808)26:23.0.co;2-1. No abstract available. |
| 8814475 | Background | Voelker KG, Chetty KG, Mahutte CK. Resolution of recurrent atelectasis in spinal cord injury patients with administration of recombinant human DNase. Intensive Care Med. 1996 Jun;22(6):582-4. doi: 10.1007/BF01708100. |
| 8711640 | Background | 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. |
| 8680379 | Background | Shah PL, Hodson ME. New treatment strategies in cystic fibrosis: rhDNase. Monaldi Arch Chest Dis. 1996 Apr;51(2):125-9. |
| 8847368 | Background | 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. |
| 11190594 | Background | 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. |
| 10708200 | Background | 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. |
| 11287830 | Background | 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. |
| 7503821 | Background | 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. |
| 10823105 | Background | Patel A, Harrison E, Durward A, Murdoch IA. Intratracheal recombinant human deoxyribonuclease in acute life-threatening asthma refractory to conventional treatment. Br J Anaesth. 2000 Apr;84(4):505-7. doi: 10.1093/oxfordjournals.bja.a013479. |
| 7570441 | Background | 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. |
| 11039936 | Background | 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. |
| Background | 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 |
| 9735080 | Background | 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. |
| ID | Term |
|---|---|
| C568813 | dornase alfa |
Not provided
Not provided
Not provided