NCT01486589

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,521

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Last Updated

February 6, 2014

Status Verified

February 1, 2014

Enrollment Period

2.7 years

First QC Date

December 2, 2011

Last Update Submit

February 5, 2014

Conditions

Autonomic Nervous System Activity

Keywords

emergency carecardiac autonomic functiondeceleration capacity

Outcome Measures

Primary Outcomes (1)

  • In-hospital mortality

    10 days

Secondary Outcomes (6)

  • Cardiac mortality

    10 days

  • transfer to intensive care unit

    10 days

  • hospital discharge

    48 hours

  • duration of hospital stay

    within 30 days

  • costs of health care

    30 days

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients presenting at the emergency department of the University Hospital of Tübingen

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medizinische Universitätsklinik Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Related Publications (2)

  • Eick C, Duckheim M, Groga-Bada P, Klumpp N, Mannes S, Zuern CS, Gawaz M, Rizas KD, Bauer A. Point-of-care testing of cardiac autonomic function for risk assessment in patients with suspected acute coronary syndromes. Clin Res Cardiol. 2017 Sep;106(9):686-694. doi: 10.1007/s00392-017-1104-3. Epub 2017 Mar 22.

    PMID: 28331988DERIVED

  • Eick C, Rizas KD, Meyer-Zurn CS, Groga-Bada P, Hamm W, Kreth F, Overkamp D, Weyrich P, Gawaz M, Bauer A. Autonomic nervous system activity as risk predictor in the medical emergency department: a prospective cohort study. Crit Care Med. 2015 May;43(5):1079-86. doi: 10.1097/CCM.0000000000000922.

    PMID: 25738854DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Axel Bauer

Study Record Dates

First Submitted

December 2, 2011

First Posted

December 6, 2011

Study Start

October 1, 2010

Primary Completion

June 1, 2013

Last Updated

February 6, 2014

Record last verified: 2014-02

Locations

DE(1)