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

September 13, 2006 updated by: University Hospital Tuebingen

Beatmungsdauer Und Lungenfunktion Bei Beatmeten Patienten Unter Therapie Mit Dornase Alfa - Randomisierte, Doppel-Blinde, Placebo-Kontrollierte, Multizentrische, Prospektive Klinische Studie

The purpose of this study is to determine whether Inhalation of Recombinant Human Deoxyribonuclease Shortens Ventilation Time in Mechanically Ventilated Adults

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment

540

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Collaborators

Joachim Riethmueller, Dr. med.

Investigators

  • Study Director: Joachim Riethmueller, Dr. med., University Children's Hospital Tuebingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Study Completion

July 1, 2006

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

September 14, 2006

Last Update Submitted That Met QC Criteria

September 13, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Other Study ID Numbers

  • LUFIT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe