Autonomic Nervous System Activity Clinical Trial
— PREDICT-EROfficial title:
Risk Stratification in the Emergency Room by Cardiac Autonomic Function
NCT number | NCT01486589 |
Other study ID # | 577/2011BO1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | December 2, 2011 |
Last updated | February 5, 2014 |
Start date | October 2010 |
Verified date | February 2014 |
Source | Thebiosignals.com |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Observational |
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.
Status | Completed |
Enrollment | 6521 |
Est. completion date | |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | Medizinische Universitätsklinik Tübingen | Tübingen | Baden-Württemberg |
Lead Sponsor | Collaborator |
---|---|
Thebiosignals.com |
Germany,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01714388 -
Vagotonic Effect of Remifentanil and Autonomic Nervous System Activity.
|
Phase 4 |