Identification of High-Risk Patients at Admission to an Emergency Department by Non-Invasive Hemodynamics

Study Overview
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Brief Summary
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The goal of this study is to evaluate the prognostic values of non-invasive hemodynamic parameteres in relation to 30-day mortality and/or acute deterioration in patients who are admitted acutely to the department of emergency medicine or cardiology.

Detailed Description
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Background Identification of critically ill and high-risk patients at hospital admission is a major triage task in the emergency department. Rapid identification and treatment of such patients improves survival, reduces complications during admission, duration of hospitalization and the costs of treatment. Reduced heart rate variability (HRV), a marker of autonomic imbalance towards sympathetic dominance, has been shown in several studies to be associated with a poor prognosis in patient groups like myocardial infarction, heart failure, ischemic heart disease, and others. Besides HRV other hemodynamic variables like cardiac stroke volume, cardiac output and peripheral resistance will potentially improve diagnosis of critically ill patients by providing better prognostic value. Aims & objectives To develop and validate a prognostic model (based on selected variables derived from Finapres measurements, HRV, CO, and TP) for 30-day mortality and/or acute deterioration in patients who are admitted acutely to the department of emergency medicine or cardiology, University Hospitals of Bispebjerg & Frederiksberg Methods & Materials The study is designed as an observational prospective cohort study. The aim is to enroll 1635 patients in total. During a period of 6 to 9 months all patients admitted to the acute medical/emergency department at Bispebjerg Hospital, Copenhagen, Denmark adn who fulfills inclusion criterias will be examined with a 10 minutes examination with the Finapres Nova device. Patients admitted to the departments of medicine/emergency medicine / Cardiology at Bispebjerg Hospital will also be included. Expected outcomes and perspectives Several scoring algorithms have been used in the emergency departments to facilitate early recognition of patients with high risk of serious outcomes. There is need to develop better clinical tools to be used in the emergency departments. The investigators expect to outperform current triage methods by including HRV and hemodynamic parameters.

Official Title
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Identification of High-Risk Patients at Admission to an Emergency Department by Non-Invasive Hemodynamics

Conditions
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Emergency Department Triage, Non-invasive Hemodynamic

Intervention / Treatment
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* Device: Finapres Nova


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Admittance with acute illness at the department of medicine/emergency medicine / Cardiology at Bispebjerg Hospital Able to give informed consent Exclusion Criteria: Terminal disease like advanced cancer or advanced organ failure with a life expectancy of less then three months. Candidate for immediate intensive care therapy Refuse or unable to give consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with acute illness<br>Patients admitted to the acute medical/emergency department and/or Cardiology department at Bispebjerg Hospital. | Device: Finapres Nova<br>* Non-invasive mesurement of hemodynamic parameters and heart rate variability<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality and/or acute deterioration. | Death within 30 days and/or cute deterioration in term of unplanned hospital admissions or unplanned transfer to the intensive therapy or any higher level of care. | 30 days from inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90-day primary outcome | 90-day primary outcome | 90 days from inclusion | 
| Major Cardiovascular Events (MACE) | Composite of cardiovascular death, non-fatal myocardial infarction, coronary revascularization, non-fatal stroke, and hospitalization because of heart failure. | 30 days from inclusion | 
| MACE 90-days | Composite of cardiovascular death, non-fatal myocardial infarction, coronary revascularization, non-fatal stroke, and hospitalization because of heart failure. | 90 days from inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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emergency department, risk prediction, non-invasive hemodynamic, Heart rate variability