Identification of High-Risk Patients at Admission to an Emergency Department by Non-Invasive Hemodynamics
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with acute illness Patients admitted to the acute medical/emergency department and/or Cardiology department at Bispebjerg Hospital. |
Device: Finapres Nova
Non-invasive mesurement of hemodynamic parameters and heart rate variability
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Outcome Measures
Primary Outcome Measures
- 30-day mortality and/or acute deterioration. [30 days from inclusion]
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.
Secondary Outcome Measures
- 90-day primary outcome [90 days from inclusion]
90-day primary outcome
- Major Cardiovascular Events (MACE) [30 days from inclusion]
Composite of cardiovascular death, non-fatal myocardial infarction, coronary revascularization, non-fatal stroke, and hospitalization because of heart failure.
- MACE 90-days [90 days from inclusion]
Composite of cardiovascular death, non-fatal myocardial infarction, coronary revascularization, non-fatal stroke, and hospitalization because of heart failure.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age > 18 years
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Admittance with acute illness at the department of medicine/emergency medicine / Cardiology at Bispebjerg Hospital
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Able to give informed consent
Exclusion Criteria:
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Terminal disease like advanced cancer or advanced organ failure with a life expectancy of less then three months.
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Candidate for immediate intensive care therapy
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Refuse or unable to give consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bispebjerg Hospital | Copenhagen | Hovedstaden | Denmark | 2400 |
Sponsors and Collaborators
- University Hospital Bispebjerg and Frederiksberg
- Doctor Sofus Carl Emil Friis and Mrs Olga Doris Friss' Fund
Investigators
- Principal Investigator: Ahmad Sajadieh, MD, DMSc, Bispebjerg Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H-18062044