Heart Rate Variability at the Emergency Department

University Hospital, Ghent (Other)
Overall Status
CT.gov ID

Study Details

Study Description

Brief Summary

In this study investigators want to examine if heart rate variability at hospital entry predicts prognosis in participants with severe disease.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Heart Rate Variability

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

Study Type:
Anticipated Enrollment :
500 participants
Observational Model:
Time Perspective:
Official Title:
Heart Rate Variabitlity at the Emergency Department: a New Triage Parameter?
Actual Study Start Date :
Oct 11, 2021
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

Diagnostic Test: Heart Rate Variability
Heart rate variability wil be calculated from patients' 10 sec ECG with a dedicated software (Kubios).

Outcome Measures

Primary Outcome Measures

  1. 30-day mortality [30 days]

Secondary Outcome Measures

  1. Length of Hospital Stay [0 - 100 days]

  2. Length of stay at the intensive care unit [0 - 100 days]

  3. Need for life threatening interventions [In 0 - 7 days after admission]

    Need for surgery, mechanical ventilation, inotropic medications, PCI or thrombolysis

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:

Patients with (possible) sepsis, myocardial infarction, cerebrovascular accident, polytrauma or Covid 19 pneumonia who were triaged red or orange following the Manchester triage system

Exclusion Criteria:

Patients with cardiac arrest or arrhythmia at arrival

Contacts and Locations


Site City State Country Postal Code
1 University Hospital Ghent - Emergency Department Gent Belgium 9000

Sponsors and Collaborators

  • University Hospital, Ghent


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • BC-08267
  • B.U.N.: B6702020000599
First Posted:
Oct 26, 2021
Last Update Posted:
May 19, 2022
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 19, 2022