Home monitoring for patients at risk of sepsis

Stop Sepsis Through Home Monitoring Cooperative

This study tests if using wearable devices and a smartphone app to monitor patients with infections at home can help catch sepsis early and keep them out of the hospital.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Antwerp (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Edegem, Antwerpen)
• Trial ID: NCT06920979 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with signs of severe acute infection who are at risk for developing sepsis.

Not a fit: Patients who are severely ill and require immediate hospitalization or have specific exclusions such as severe confusion or ongoing immunosuppressive therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly lower the incidence of severe sepsis and improve patient outcomes through timely interventions.

How similar studies have performed: While this approach is innovative, similar telemonitoring strategies have shown promise in other conditions, suggesting potential for success in this context.

Eligibility criteria

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 this trial is running

Edegem, Antwerpen

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

Study contacts

• Study coordinator: Celine Maes, PHD

Conditions Sepsis; Home Monitoring Follow-up; Infection; Innovativeness