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

NCT ID: NCT03934775

Last Updated: 2023-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

942 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-13

Study Completion Date

2023-05-26

Brief Summary

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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

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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.

Conditions

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Emergency Department Triage Non-invasive Hemodynamic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with acute illness

Patients admitted to the acute medical/emergency department and/or Cardiology department at Bispebjerg Hospital.

Finapres Nova

Intervention Type DEVICE

Non-invasive mesurement of hemodynamic parameters and heart rate variability

Interventions

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Finapres Nova

Non-invasive mesurement of hemodynamic parameters and heart rate variability

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Doctor Sofus Carl Emil Friis and Mrs Olga Doris Friss' Fund

UNKNOWN

Sponsor Role collaborator

University Hospital Bispebjerg and Frederiksberg

OTHER

Sponsor Role lead

Responsible Party

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Ahmad Sajadieh

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmad Sajadieh, MD, DMSc

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

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Bispebjerg Hospital

Copenhagen, Capital Region, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-18062044

Identifier Type: -

Identifier Source: org_study_id

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