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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03934775
Enrollment
942
Registered
2019-05-02
Start date
2019-05-13
Completion date
2023-05-26
Last updated
2023-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergency Department Triage, Non-invasive Hemodynamic

Keywords

emergency department, risk prediction, non-invasive hemodynamic, Heart rate variability

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.

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.

Interventions

Non-invasive mesurement of hemodynamic parameters and heart rate variability

Sponsors

Doctor Sofus Carl Emil Friis and Mrs Olga Doris Friss' Fund
CollaboratorUNKNOWN
University Hospital Bispebjerg and Frederiksberg
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
30-day mortality and/or acute deterioration.30 days from inclusionDeath 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

MeasureTime frameDescription
90-day primary outcome90 days from inclusion90-day primary outcome
Major Cardiovascular Events (MACE)30 days from inclusionComposite of cardiovascular death, non-fatal myocardial infarction, coronary revascularization, non-fatal stroke, and hospitalization because of heart failure.
MACE 90-days90 days from inclusionComposite of cardiovascular death, non-fatal myocardial infarction, coronary revascularization, non-fatal stroke, and hospitalization because of heart failure.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026