Relevance of Biomarkers in the Process of Weaning

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Heidelberg University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT01341561
First received: April 13, 2011
Last updated: April 22, 2011
Last verified: March 2011
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 13, 2011
Last Updated: April 22, 2011
Health Authority: Germany: Ethics committee

ClinicalTrials.gov processed this record on July 29, 2014