Emergency Department TriageNCT03934775
Identification of High-Risk Patients at Admission to an Emergency Department by Non-Invasive Hemodynamics
An observational study of Emergency Department Triage and Non-invasive Hemodynamic, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Department Triage, Non-invasive Hemodynamic
- What is being tested?
- Finapres Nova
- Type of treatment
- Medical device
- How many people
- 942 participants
- Where
- 1 siteDenmark
- Study dates
- 13 May 2019to 26 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population is patients admitted to the department of emergency medicin and/or cardiology department at Bispebjerg Hospital, Copenhagen, Denmark.
Who may be able to join
- Age > 18 years
- Admittance with acute illness at the department of medicine/emergency medicine / Cardiology at Bispebjerg Hospital
- Able to give informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Finapres Nova
- Keywords
- emergency department, risk prediction, non-invasive hemodynamic, Heart rate variability
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finapres NovaDevice
Non-invasive mesurement of hemodynamic parameters and heart rate variability
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute illness | Patients admitted to the acute medical/emergency department and/or Cardiology department at Bispebjerg Hospital. Receives: Device: Finapres Nova |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days from inclusion
Secondary outcomes (3)
90-day primary outcome
90-day primary outcome
Measured: 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.
Measured: 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.
Measured: 90 days from inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start13 May 2019
- Primary completion30 Jan 2023
- Study completion26 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emergency Department TriageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 942 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Collaborators
- Doctor Sofus Carl Emil Friis and Mrs Olga Doris Friss' Fund
- Responsible party
- Principal investigator, Ahmad Sajadieh, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Ahmad Sajadieh, MD, DMSc, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934775
- Sponsor's protocol ID
- H-18062044
- Status last verified
- Jul 2023
- First submitted
- 29 Apr 2019
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Malm EHJ, Warrad W, Hadad R, Asmar A, Dominguez H, Haugaard SB, Sajadieh A. Is hyperdynamic circulation a hallmark of obesity? Int J Obes (Lond). 2026 Mar;50(3):618-625. doi: 10.1038/s41366-025-01981-5. Epub 2025 Dec 12.
PubMed 41388148
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of High-Risk Patients at Admission to an Emergency Department by Non-Invasive Hemodynamics
- ClinicalTrials.gov ID
- NCT03934775
- Acronym / sponsor ID
- H-18062044
- Keywords
- emergency department, risk prediction, non-invasive hemodynamic, Heart rate variability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 942 participants (actual)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Collaborators
- Doctor Sofus Carl Emil Friis and Mrs Olga Doris Friss' Fund
- Study start
- 13 May 2019 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 26 May 2023 (actual)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute illness | – | Device: Finapres NovaPatients admitted to the acute medical/emergency department and/or Cardiology department at Bispebjerg Hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population is patients admitted to the department of emergency medicin and/or cardiology department at Bispebjerg Hospital, Copenhagen, Denmark.
Key inclusion criteria (3 listed)
- Age > 18 years
- Admittance with acute illness at the department of medicine/emergency medicine / Cardiology at Bispebjerg Hospital
- Able to give informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finapres NovaNon-invasive mesurement of hemodynamic parameters and heart rate variability | Device | Patients with acute illness |
Primary outcome
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.
3 secondary outcomes
90-day primary outcome
Time frame: 90 days from inclusion
Major Cardiovascular Events (MACE)
Time frame: 30 days from inclusion
MACE 90-days
Time frame: 90 days from inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Derived from this study: PubMed 41388148Malm EHJ, Warrad W, Hadad R, Asmar A, Dominguez H, Haugaard SB, Sajadieh A. Is hyperdynamic circulation a hallmark of obesity? Int J Obes (Lond). 2026 Mar;50(3):618-625. doi: 10.1038/s41366-025-01981-5. Epub 2025 Dec 12.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmad Sajadieh, MD, DMSc principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergency Department Triage and Non-invasive Hemodynamic, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day mortality and/or acute deterioration. (time frame: 30 days from inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03934775, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.