Beatmungsdauer Und Lungenfunktion Bei Beatmeten Patienten Unter Therapie Mit Dornase Alfa - Randomisierte, Doppel-Blinde, Placebo-Kontrollierte, Multizentrische, Prospektive Klinische Studie
试验速览
- 阶段
- 2 期
- 入组人数
- 540
- 试验地点
- 50
- 主要终点
- Time of mechanical ventilation from beginning of the ventilation-therapy up to the end of the ventilation-therapy
研究概览
简要总结
The purpose of this study is to determine whether Inhalation of Recombinant Human Deoxyribonuclease Shortens Ventilation Time in Mechanically Ventilated Adults
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mechanical ventilation
- •expected ventilation time 3 days or longer
- •full therapy is possible
- •expectet ventilation time not longer than 21 days
排除标准
- •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
结局指标
主要结局
Time of mechanical ventilation from beginning of the ventilation-therapy up to the end of the ventilation-therapy
次要结局
- reduction of atelectasis / dystelectasis
- improval of pulmonaryfunction
- reduction of pneumonia
- reduction of DNA concentrations in Airway Secretions
- length of stay at the Intensive Care Unit
- length of stay at the hospital