Heart Rate VariabilityNCT05093439
Heart Rate Variability At the Emergency Department
An observational study of Heart Rate Variability and Emergency Department, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
In this study investigators want to examine if heart rate variability at hospital entry predicts prognosis in participants with severe disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Rate Variability, Emergency Department
- What is being tested?
- Heart Rate Variability
- How many people
- 532 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Oct 2021to 1 Jun 2022
- 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: Patients presenting at the Emergency Department with severe disease
Who may be able to join
- Patients with (possible) sepsis, myocardial infarction, cerebrovascular accident, polytrauma or Covid 19 pneumonia who were triaged red or orange following the Manchester triage system
Who cannot join
- Patients with cardiac arrest or arrhythmia at arrival
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heart Rate Variabitlity At the Emergency Department: a New Triage Parameter?
In this study investigators want to examine if heart rate variability at hospital entry predicts prognosis in participants with severe disease.
Read the detailed description
Predictive parameters that can predict the outcome are very scarce. Vital parameters such as heart rate, blood pressure, saturation, etc. can be normal for a long time or only slightly changed, even in seriously ill patients. Heart rate variability is a parameter that can be used as a measure of autonomic dysfunction. Lower heart rate variability is associated with increased mortality and morbidity according to recent studies. Heart rate variability could thus be used to identify the need for intervention and treatment more quickly.
In this study, we want to investigate whether there is indeed a relationship between heart rate variability at admission to the emergency department and eventual mortality and morbidity in critically ill patients.
Therefore, heart rate variability will be determined in patients admitted to the emergency department who were triaged in red or orange according to the Manchester Triage System (internationally validated triage system that is also used in the emergency department at UZ Gent). Subanalyses will be made for patients with trauma, sepsis, pneumonia, CVA and acute myocardial infarction. Determination of heart rate variability will be done by EKG monitoring during the first 5 minutes and after 3 hours. There are several parameters that can reflect heart rate variability. Both frequency domain measurements and non-linair measurements will be determined. Use will be made of the Kubios programme, a free programme that can determine these different parameters on the basis of EKG monitoring. Patients who are resuscitated on arrival will be excluded, as well as patients in VKF, as the heart rate variability on arrival cannot be determined for these two groups. Demographic data (age, sex,...), history and home medication, vital parameters (heart rate, blood pressure, saturation, temperature, respiratory rate) and some lab data (lactate, CRP) will also be collected. The primary outcome will be mortality after 30 days. Secondary outcomes that will be studied are the total duration of hospital stay and the duration of stay in the intensive care unit, as well as the need for life-saving interventions (need for surgery, ventilation, inotropics, PCI or thrombolysis).
By collecting these data, we want to find out whether heart rate variability is a good predictor of outcome, and thus the need for ICU admission, faster invasive interventions,... During this study, the patient's management will remain unchanged.
- Conditions
- Heart Rate Variability, Emergency Department
- Being tested
- 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.
Heart Rate VariabilityDiagnostic test
Heart rate variability wil be calculated from patients' 10 sec ECG with a dedicated software (Kubios).
| Study group | Role | What they receive |
|---|---|---|
| Patients presenting at Emergency Department with severe disease | Participants will be patients with (possible) sepsis, myocardial infarction, cerebrovascular accident, polytrauma or Covid 19 pneumonia who were triaged red or orange following the Manchester triage system. Receives: Diagnostic Test: Heart Rate Variability |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
Measured: 30 days
Secondary outcomes (3)
Length of Hospital Stay
Measured: 0 - 100 days
Length of stay at the intensive care unit
Measured: 0 - 100 days
Need for life threatening interventions
Need for surgery, mechanical ventilation, inotropic medications, PCI or thrombolysis
Measured: In 0 - 7 days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start11 Oct 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Rate VariabilityStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 532 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093439
- Sponsor's protocol ID
- BC-08267
- Other IDs
- B.U.N.: B6702020000599
- Status last verified
- Sep 2024
- First submitted
- 13 Oct 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Variabitlity At the Emergency Department: a New Triage Parameter?
- ClinicalTrials.gov ID
- NCT05093439
- Acronym / sponsor ID
- BC-08267
- Conditions
- Heart Rate Variability, Emergency Department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 532 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 26 Oct 2021 (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.
In this study investigators want to examine if heart rate variability at hospital entry predicts prognosis in participants with severe disease.
Detailed description
Predictive parameters that can predict the outcome are very scarce. Vital parameters such as heart rate, blood pressure, saturation, etc. can be normal for a long time or only slightly changed, even in seriously ill patients. Heart rate variability is a parameter that can be used as a measure of autonomic dysfunction. Lower heart rate variability is associated with increased mortality and morbidity according to recent studies. Heart rate variability could thus be used to identify the need for intervention and treatment more quickly.
In this study, we want to investigate whether there is indeed a relationship between heart rate variability at admission to the emergency department and eventual mortality and morbidity in critically ill patients.
Therefore, heart rate variability will be determined in patients admitted to the emergency department who were triaged in red or orange according to the Manchester Triage System (internationally validated triage system that is also used in the emergency department at UZ Gent). Subanalyses will be made for patients with trauma, sepsis, pneumonia, CVA and acute myocardial infarction. Determination of heart rate variability will be done by EKG monitoring during the first 5 minutes and after 3 hours. There are several parameters that can reflect heart rate variability. Both frequency domain measurements and non-linair measurements will be determined. Use will be made of the Kubios programme, a free programme that can determine these different parameters on the basis of EKG monitoring. Patients who are resuscitated on arrival will be excluded, as well as patients in VKF, as the heart rate variability on arrival cannot be determined for these two groups. Demographic data (age, sex,...), history and home medication, vital parameters (heart rate, blood pressure, saturation, temperature, respiratory rate) and some lab data (lactate, CRP) will also be collected. The primary outcome will be mortality after 30 days. Secondary outcomes that will be studied are the total duration of hospital stay and the duration of stay in the intensive care unit, as well as the need for life-saving interventions (need for surgery, ventilation, inotropics, PCI or thrombolysis).
By collecting these data, we want to find out whether heart rate variability is a good predictor of outcome, and thus the need for ICU admission, faster invasive interventions,... During this study, the patient's management will remain unchanged.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients presenting at Emergency Department with severe disease | – | Diagnostic Test: Heart Rate VariabilityParticipants will be patients with (possible) sepsis, myocardial infarction, cerebrovascular accident, polytrauma or Covid 19 pneumonia who were triaged red or orange following the Manchester triage system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting at the Emergency Department with severe disease
Key inclusion criteria (1 listed)
- Patients with (possible) sepsis, myocardial infarction, cerebrovascular accident, polytrauma or Covid 19 pneumonia who were triaged red or orange following the Manchester triage system
Key exclusion criteria (1 listed)
- Patients with cardiac arrest or arrhythmia at arrival
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 |
|---|---|---|
| Heart Rate VariabilityHeart rate variability wil be calculated from patients' 10 sec ECG with a dedicated software (Kubios). | Diagnostic test | Patients presenting at Emergency Department with severe disease |
Primary outcome
30-day mortality
Time frame: 30 days
3 secondary outcomes
Length of Hospital Stay
Time frame: 0 - 100 days
Length of stay at the intensive care unit
Time frame: 0 - 100 days
Need for life threatening interventions
Time frame: In 0 - 7 days after admission
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 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Heart Rate Variability and Emergency Department, run by University Hospital, Ghent at 1 site in Belgium.
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 1 inclusion and 1 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 19 Sep 2024. 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 Belgium. 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 (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.