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Relevance of Biomarkers in the Process of Weaning

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by Heidelberg University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01341561
First Posted: April 25, 2011
Last Update Posted: April 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Heidelberg University
  Purpose
The purpose of the study is to examine the relevance of biochemical markers (specific pulmonary and cardiac markers and markers of endogenous stress) in the process of weaning in patients with artificial ventilation.

Condition
Duration of Weaning

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Relevance of Biochemical Markers in the Process of Weaning

Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • success of weaning [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 30days ]
    primary outcome measure is the success of weaning during hospital stay. Duration of hospital stay is estimated between 1-60days, in average 30days. Criteria is spontaneous breathing.


Secondary Outcome Measures:
  • follow up [ Time Frame: 12 months ]
    Follow up is done after 12 months to check major adverse cardiac or pulmonary events (death, myocardial infarction, re-hospitalisation)


Biospecimen Retention:   Samples With DNA
routine blood parameters

Estimated Enrollment: 100
Study Start Date: April 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
weaning patients

Detailed Description:
Artificially ventilated patients on our intensive care unit will be monitored if specific biomarkers have a relevance in risk stratification, optimizing therapy, outcome and success in the process of weaning. Therefore, consecutively, specific blood parameters will be taken at time of intubation,day 1 of weaning and extubation.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
consecutively all patients on our intensive care unit who are artificially ventilated
Criteria

Inclusion Criteria:

  • Written informed consent
  • Able and willing to understand the protocol
  • At least 18 years or older

Exclusion Criteria:

  • Not fulfilling inclusion criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01341561


Contacts
Contact: Evangelos Giannitsis, Prof. Dr. 0049-6221-56-38686 Evangelos_Giannitsis@med.uni-heidelberg.de

Locations
Germany
Intensive Care Unit, University of Heidelberg Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Evangelos Giannitsis, Prof. Dr.    004962215638686    Evangelos_Giannitsis@med.uni-heidelberg.de   
Sponsors and Collaborators
Heidelberg University
  More Information

Responsible Party: Prof. Dr. Evangelos Giannitsis, Department of Cardiology, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01341561     History of Changes
Other Study ID Numbers: TnT hs 4
First Submitted: April 13, 2011
First Posted: April 25, 2011
Last Update Posted: April 25, 2011
Last Verified: March 2011