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Completed

NCT Number: NCT05093439

Heart Rate Variability At the Emergency Department

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Ghent - Emergency Department

Ghent, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heart Rate Variability

Diagnostic Test

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

Primary outcomes

  1. 30-day mortality

    Time frame: 30 days

Secondary outcomes

  1. Length of Hospital Stay

    Time frame: 0 - 100 days

  2. Length of stay at the intensive care unit

    Time frame: 0 - 100 days

  3. Need for life threatening interventions

    Time frame: In 0 - 7 days after admission

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

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

Heart Rate Variabitlity At the Emergency Department: a New Triage Parameter?

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 26, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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