An observational study in Emergency Department Triage and Non-invasive Hemodynamic, sponsored by University Hospital Bispebjerg and Frederiksberg. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-20.
Sponsored by University Hospital Bispebjerg and Frederiksberg · Observational
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.
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.
1,694 studies on the registry are indexed under Emergencies; 332 are open to participants now.
This study's enrollment of 942 is above the median of 350 across 715 observational studies indexed under Emergencies.
Browse Emergencies studies →University Hospital Bispebjerg and Frederiksberg is the lead sponsor of 68 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Population is patients admitted to the department of emergency medicin and/or cardiology department at Bispebjerg Hospital, Copenhagen, Denmark.
Exclusion Criteria:
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
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.
Time frame: 30 days from inclusion
90-day primary outcome
90-day primary outcome
Time frame: 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.
Time frame: 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.
Time frame: 90 days from inclusion
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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University Hospital Bispebjerg and Frederiksberg