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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Axel Bauer, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01486589
First received: December 2, 2011
Last updated: February 5, 2014
Last verified: February 2014
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: December 2, 2011
Last Updated: February 5, 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

ClinicalTrials.gov processed this record on August 22, 2017