- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01486589
Cardiac Autonomic Function For Risk Stratification in the Emergency Room (PREDICT-ER)
February 5, 2014 updated by: Axel Bauer, Thebiosignals.com
Risk Stratification in the Emergency Room by Cardiac Autonomic Function
The aim of the study is to test the hypothesis that impaired cardiac autonomic function predicts adverse outcome in unselected patients presenting in the emergency ward.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
6521
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
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Baden-Württemberg
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Tübingen, Baden-Württemberg, Germany, 72076
- Medizinische Universitätsklinik Tübingen
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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
Non-Probability Sample
Study Population
Consecutive patients presenting at the emergency department of the University Hospital of Tübingen
Description
Inclusion Criteria:
- presenting at the emergency department of the University Hospital of Tübingen
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
In-hospital mortality
Time Frame: 10 days
|
10 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
180 day mortality
Time Frame: 180 days
|
180 days
|
Cardiac mortality
Time Frame: 10 days
|
10 days
|
transfer to intensive care unit
Time Frame: 10 days
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10 days
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hospital discharge
Time Frame: 48 hours
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48 hours
|
duration of hospital stay
Time Frame: within 30 days
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within 30 days
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costs of health care
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Eick C, Duckheim M, Groga-Bada P, Klumpp N, Mannes S, Zuern CS, Gawaz M, Rizas KD, Bauer A. Point-of-care testing of cardiac autonomic function for risk assessment in patients with suspected acute coronary syndromes. Clin Res Cardiol. 2017 Sep;106(9):686-694. doi: 10.1007/s00392-017-1104-3. Epub 2017 Mar 22.
- Eick C, Rizas KD, Meyer-Zurn CS, Groga-Bada P, Hamm W, Kreth F, Overkamp D, Weyrich P, Gawaz M, Bauer A. Autonomic nervous system activity as risk predictor in the medical emergency department: a prospective cohort study. Crit Care Med. 2015 May;43(5):1079-86. doi: 10.1097/CCM.0000000000000922.
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
October 1, 2010
Primary Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
December 2, 2011
First Submitted That Met QC Criteria
December 5, 2011
First Posted (Estimate)
December 6, 2011
Study Record Updates
Last Update Posted (Estimate)
February 6, 2014
Last Update Submitted That Met QC Criteria
February 5, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 577/2011BO1
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.
Clinical Trials on Autonomic Nervous System Activity
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Mahidol UniversityChulalongkorn UniversityUnknownPhysical Activity | Emotions | Autonomic Nervous System Imbalance
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-
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The Hong Kong Polytechnic UniversityUnknownAutonomic Nervous System DisorderChina
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Northwell HealthEnrolling by invitationAutonomic Nervous System Diseases | Autonomic Dysfunction | Autonomic Imbalance | Vagus Nerve Autonomic DisorderUnited States
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Istanbul Medipol University HospitalCompletedVagus Nerve Autonomic DisorderTurkey
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Virginia Polytechnic Institute and State UniversityNot yet recruiting