- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01341561
Relevance of Biomarkers in the Process of Weaning
April 22, 2011 updated by: Heidelberg University
The Relevance of Biochemical Markers in the Process of Weaning
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.
Study Overview
Status
Unknown
Conditions
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
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Baden-Württemberg
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Heidelberg, Baden-Württemberg, Germany, 69120
- Recruiting
- Intensive Care Unit, University of Heidelberg
-
Contact:
- Evangelos Giannitsis, Prof. Dr.
- Phone Number: 004962215638686
- Email: Evangelos_Giannitsis@med.uni-heidelberg.de
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
consecutively all patients on our intensive care unit who are artificially ventilated
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
weaning patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
participants will be followed for the duration of hospital stay, an expected average of 30days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Anticipated)
April 1, 2012
Study Completion (Anticipated)
April 1, 2013
Study Registration Dates
First Submitted
April 13, 2011
First Submitted That Met QC Criteria
April 22, 2011
First Posted (Estimate)
April 25, 2011
Study Record Updates
Last Update Posted (Estimate)
April 25, 2011
Last Update Submitted That Met QC Criteria
April 22, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- TnT hs 4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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