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Relevance of Biomarkers in the Process of Weaning

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. Identifier: NCT01341561
Recruitment Status : Unknown
Verified March 2011 by Heidelberg University.
Recruitment status was:  Recruiting
First Posted : April 25, 2011
Last Update Posted : April 25, 2011
Information provided by:
Heidelberg University

Brief Summary:
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 or disease
Duration of Weaning

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.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Relevance of Biochemical Markers in the Process of Weaning
Study Start Date : April 2011
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : April 2013

weaning patients

Primary Outcome Measures :
  1. 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 :
  1. 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

Information from the National Library of Medicine

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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

Inclusion Criteria:

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

Exclusion Criteria:

  • Not fulfilling inclusion criteria

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 identifier (NCT number): NCT01341561

Contact: Evangelos Giannitsis, Prof. Dr. 0049-6221-56-38686

Intensive Care Unit, University of Heidelberg Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Evangelos Giannitsis, Prof. Dr.    004962215638686   
Sponsors and Collaborators
Heidelberg University

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