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

Emergency Department Triage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03934775
• Other study ID #: H-18062044
• Status: Completed
• Start date: May 13, 2019
• Est. completion date: May 26, 2023

Study information

• Verified date: July 2023
• Source: University Hospital Bispebjerg and Frederiksberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 942
• Est. completion date: May 26, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Emergency Department Triage
• Non-invasive Hemodynamic

Intervention

Device:
• Finapres Nova
Non-invasive mesurement of hemodynamic parameters and heart rate variability

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen	Hovedstaden

Sponsors (2)

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

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	90-day primary outcome	90-day primary outcome	90 days from inclusion
Secondary	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
Secondary	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