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Clinical Trials/NCT03934775
NCT03934775
Completed
Not Applicable

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

University Hospital Bispebjerg and Frederiksberg1 site in 1 country942 target enrollmentMay 13, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Emergency Department Triage
Sponsor
University Hospital Bispebjerg and Frederiksberg
Enrollment
942
Locations
1
Primary Endpoint
30-day mortality and/or acute deterioration.
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 13, 2019
End Date
May 26, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital Bispebjerg and Frederiksberg
Responsible Party
Principal Investigator
Principal Investigator

Ahmad Sajadieh

Associate professor

University Hospital Bispebjerg and Frederiksberg

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

Outcomes

Primary Outcomes

30-day mortality and/or acute deterioration.

Time Frame: 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 Outcomes

  • 90-day primary outcome(90 days from inclusion)
  • Major Cardiovascular Events (MACE)(30 days from inclusion)
  • MACE 90-days(90 days from inclusion)

Study Sites (1)

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