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

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.

Study Overview

• Status: Completed
• Conditions: Emergency Department Triage; Non-invasive Hemodynamic
• Intervention / Treatment: Device: Finapres Nova

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 Type: Observational
• Enrollment (Actual): 942

Contacts and Locations

Study Locations

• Denmark
  • Hovedstaden
    • Copenhagen, Hovedstaden, Denmark, 2400
      • Bispebjerg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Population is patients admitted to the department of emergency medicin and/or cardiology department at Bispebjerg Hospital, Copenhagen, Denmark.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Bispebjerg and Frederiksberg
• Collaborators: Doctor Sofus Carl Emil Friis and Mrs Olga Doris Friss' Fund
• Investigators: Principal Investigator: Ahmad Sajadieh, MD, DMSc, Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2019
• Primary Completion (Actual): January 30, 2023
• Study Completion (Actual): May 26, 2023

Study Registration Dates

• First Submitted: April 29, 2019
• First Submitted That Met QC Criteria: April 29, 2019
• First Posted (Actual): May 2, 2019

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: emergency department; Heart rate variability; risk prediction; non-invasive hemodynamic
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: H-18062044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No