NCT05093439

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
532

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

8 months

First QC Date

October 13, 2021

Last Update Submit

September 5, 2024

Conditions

Heart Rate VariabilityEmergency Department

Outcome Measures

Primary Outcomes (1)

  • 30-day mortality

    30 days

Secondary Outcomes (3)

  • Length of Hospital Stay

    0 - 100 days

  • Length of stay at the intensive care unit

    0 - 100 days

  • Need for life threatening interventions

    In 0 - 7 days after admission

Study Arms (1)

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

Interventions

Heart Rate VariabilityDIAGNOSTIC_TEST

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

Patients presenting at Emergency Department with severe disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients presenting at the Emergency Department with severe disease

You may qualify if:

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

You may not qualify if:

  • Patients with cardiac arrest or arrhythmia at arrival

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent - Emergency Department

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2021

First Posted

October 26, 2021

Study Start

October 11, 2021

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)