Home monitoring for patients at risk of sepsis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study follows patients with acute infections who are at risk of developing sepsis using wearable devices that continuously monitor vital signs and a smartphone application for follow-up. It aims to provide transmural care through telemonitoring, allowing for active monitoring in a home setting to reduce hospitalizations and emergency department visits. The goal is to enable rapid intervention if patients' conditions deteriorate, ultimately reducing morbidity, mortality, and healthcare costs associated with sepsis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* This study will include patients aged 18 years or older, capable of giving informed consent, presenting with signs of severe acute infection with a risk of developing sepsis at the emergency department or at their primary care physician.

Exclusion Criteria:

* Patients that are severely ill and require immediate hospitalization Qucik Sepsis Related Organ Failure score (QSOFA) ≥ 1 National Early Warning Score (NEWS) ≥ 5
* Patients that demonstrate confusion, changes in mental state and/or an Mini-Mental State Examination (MMSE) below 26
* Presence of neuropenic fever
* Patients currently undergoing immunosuppressive therapy or chemotherapy
* Patients with human immunodeficiency virus (HIV) or Acquired Immune Deficiency Syndrome (AIDS)
* Suspicion of appendicitis, suspicion of meningitis or meningeal irritation, suspicion of or high risk of developing endocarditis
* Complicated operation wounds at the time of screening
* Proven pneumonia (CURB 65 score ≥ 1)
* Emphysema, Chronic Obstructive Pulmonary Disease (COPD) GOLD \>1 or interstitial lung disease
* Patients with oxygen at home \> 2 l/min on a chronic basis (severe underlying lung disease?)
* Severe cardiovascular disease including:

  * Severe heart failure New York Heart Association (NYHA) class \> 1
  * Endoprosthesis
  * Cardiac arrhythmia including atrial fibrillation
  * Severe heart valve abnormalities
  * Mechanic valve replacement
  * Recent acute myocardial infarct or coronarography (less than 1y ago)
  * Severe peripheral vascular morbidity
* Acute chest pain (suspicion of acute coronary pathology)
* Suspicion of/chance of septic arthritis

Where it's running

• Antwerp University Hospital (UZA)
  Edegem, Antwerpen, Belgium Recruiting

Study contacts

• Study coordinator: Celine Maes, PHD
• Email: thuisopvolging@uza.be
• Phone: +32 3 436 81 65

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.