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Cardiac Autonomic Function For Risk Stratification in the Emergency Room (PREDICT-ER)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01486589
First Posted: December 6, 2011
Last Update Posted: February 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Axel Bauer, University Hospital Tuebingen
  Purpose
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.

Condition
Autonomic Nervous System Activity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Stratification in the Emergency Room by Cardiac Autonomic Function

Further study details as provided by Axel Bauer, University Hospital Tuebingen:

Primary Outcome Measures:
  • In-hospital mortality [ Time Frame: 10 days ]

Secondary Outcome Measures:
  • Cardiac mortality [ Time Frame: 10 days ]
  • transfer to intensive care unit [ Time Frame: 10 days ]
  • hospital discharge [ Time Frame: 48 hours ]
  • duration of hospital stay [ Time Frame: within 30 days ]
  • costs of health care [ Time Frame: 30 days ]
  • 180 day mortality [ Time Frame: 180 days ]

Enrollment: 6521
Study Start Date: October 2010
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients presenting at the emergency department of the University Hospital of Tübingen
Criteria

Inclusion Criteria:

- presenting at the emergency department of the University Hospital of Tübingen

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01486589


Locations
Germany
Medizinische Universitätsklinik Tübingen
Tübingen, Baden-Württemberg, Germany, 72076
Sponsors and Collaborators
Thebiosignals.com
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Axel Bauer, Prof. Dr. Axel Bauer, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01486589     History of Changes
Other Study ID Numbers: 577/2011BO1
First Submitted: December 2, 2011
First Posted: December 6, 2011
Last Update Posted: February 6, 2014
Last Verified: February 2014

Keywords provided by Axel Bauer, University Hospital Tuebingen:
emergency care
cardiac autonomic function
deceleration capacity

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes