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

Phase 3UnknownNCT00204685

University Hospital Tuebingen540 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

540

Conditions

Long Term Ventilation

Interventions

dornase alfaDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (25)

Outcomes

Primary Outcomes

Time of mechanical ventilation from beginning of the ventilation-therapy up to the end of the ventilation-therapy

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

...and 15 more locations