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

Resource links provided by NLM:


Further study details as provided by Thebiosignals.com:

Primary Outcome Measures:
  • In-hospital mortality [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiac mortality [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • transfer to intensive care unit [ Time Frame: 10 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 ]
  • 180 day mortality [ Time Frame: 180 days ] [ Designated as safety issue: No ]

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
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
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

No publications provided

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
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 September 30, 2014