Clinical trial NCT03934775: Identification of High-Risk Patients at Admission to an Emergency Department by Non-Invasive Hemodynamics
Official title: Identification of High-Risk Patients at Admission to an Emergency Department by Non-Invasive Hemodynamics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergency Department Triage
Non-invasive Hemodynamic
Keywords: emergency department
risk prediction
non-invasive hemodynamic
Heart rate variability
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
Collaborators: name: Doctor Sofus Carl Emil Friis and Mrs Olga Doris Friss' Fund
First posted: 2019-05-02
Enrollment: 942
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 30-day mortality and/or acute deterioration.
timeFrame: 30 days from inclusion
Secondary outcomes:
measure: 90-day primary outcome
timeFrame: 90 days from inclusion
measure: Major Cardiovascular Events (MACE)
timeFrame: 30 days from inclusion
measure: MACE 90-days
timeFrame: 90 days from inclusion
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: Hovedstaden
Study officials:
affiliation: Bispebjerg Hospital
name: Ahmad Sajadieh, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References: