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

Completed

• Conditions: Non-invasive Hemodynamic; Emergency Department Triage
• Interventions: Device: Finapres Nova

• Registration Number: NCT03934775
• Lead Sponsor: University Hospital Bispebjerg and Frederiksberg

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.

Study Timeline

• Study First Submitted: 2019-04-29
• Study First Submitted QC: 2019-04-29
• Study First Posted: 2019-05-02
• Study Start: 2019-05-13
• Primary Completion: 2023-01-30
• Study Completion: 2023-05-26
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 942

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with acute illness	Finapres Nova	Patients admitted to the acute medical/emergency department and/or Cardiology department at Bispebjerg Hospital.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Bispebjerg Hospital; 🇩🇰 Copenhagen, Hovedstaden, Denmark