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 University of Heidelberg.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Heidelberg
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01341561
First received: April 13, 2011
Last updated: April 22, 2011
Last verified: March 2011
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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 University of Heidelberg:
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
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
University of Heidelberg
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 May 23, 2013