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

This study is currently recruiting participants.
Verified December 2011 by Thebiosignals.com
Sponsor:
Information provided by (Responsible Party):
Axel Bauer, Thebiosignals.com
ClinicalTrials.gov Identifier:
NCT01486589
First received: December 2, 2011
Last updated: December 5, 2011
Last verified: December 2011
  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
Cardiac Function Impaired

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 Thebiosignals.com:

Primary Outcome Measures:
  • In-hospital mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiac mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • transfer to intensive care unit [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • hospital discharge [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • duration of hospital stay [ Time Frame: within 30 days ] [ Designated as safety issue: No ]
  • costs of health care [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 10000
Study Start Date: October 2010
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486589

Locations
Germany
Medizinische Universitätsklinik Tübingen Recruiting
Tübingen, Baden-Württemberg, Germany, 72076
Contact: Axel Bauer, MD     0049-7071-29 ext 82922     axel.bauer@med.uni-tuebingen.de    
Principal Investigator: Axel Bauer, MD            
Sponsors and Collaborators
Thebiosignals.com
  More Information

No publications provided

Responsible Party: Axel Bauer, Prof. Dr. Axel Bauer, Thebiosignals.com
ClinicalTrials.gov Identifier: NCT01486589     History of Changes
Other Study ID Numbers: 577/2011BO1
Study First Received: December 2, 2011
Last Updated: December 5, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Thebiosignals.com:
emergency care
cardiac autonomic function
deceleration capacity

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013