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NCT01341561 Clinical Trial

Relevance of Biomarkers in the Process of Weaning

Duration of Weaning Clinical Trial

Official title:
The Relevance of Biochemical Markers in the Process of Weaning

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01341561
Other study ID # TnT hs 4
Secondary ID
Status Recruiting
Phase N/A
First received April 13, 2011
Last updated April 22, 2011
Start date April 2011
Est. completion date April 2013

Study information
Verified date March 2011
Source Heidelberg University
Contact Evangelos Giannitsis, Prof. Dr.
Phone 0049-6221-56-38686
Email Evangelos_Giannitsis@med.uni-heidelberg.de
Is FDA regulated No
Health authority Germany: Ethics committee
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date April 2013
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Written informed consent

- Able and willing to understand the protocol

- At least 18 years or older

Exclusion Criteria:

- Not fulfilling inclusion criteria

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Intensive Care Unit, University of Heidelberg Heidelberg Baden-Württemberg

Sponsors (1)
Lead Sponsor Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary success of weaning 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. participants will be followed for the duration of hospital stay, an expected average of 30days No
Secondary follow up Follow up is done after 12 months to check major adverse cardiac or pulmonary events (death, myocardial infarction, re-hospitalisation) 12 months No