Cardiac Autonomic Function For Risk Stratification in the Emergency Room

Autonomic Nervous System Activity Clinical Trial

— PREDICT-ER  

Official title:

Risk Stratification in the Emergency Room by Cardiac Autonomic Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01486589
• Other study ID #: 577/2011BO1
• Status: Completed
• Phase: N/A
• First received: December 2, 2011
• Last updated: February 5, 2014
• Start date: October 2010

Study information

• Verified date: February 2014
• Source: Thebiosignals.com
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6521
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Autonomic Nervous System Activity
• Emergencies

Locations

Country	Name	City	State
Germany	Medizinische Universitätsklinik Tübingen	Tübingen	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Thebiosignals.com

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital mortality		10 days	No
Secondary	Cardiac mortality		10 days	No
Secondary	transfer to intensive care unit		10 days	No
Secondary	hospital discharge		48 hours	No
Secondary	duration of hospital stay		within 30 days	No
Secondary	costs of health care		30 days	No
Secondary	180 day mortality		180 days	No