Image

Stop Sepsis Through Home Monitoring Cooperative

Stop Sepsis Through Home Monitoring Cooperative

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

In this study, patients presenting with acute infections at risk of developing sepsis will be followed in their home setting using wearables that provide (semi-)continue monitoring of vital signs as well as through follow up using a designated smartphone application. This is an innovative pilot study that will examine the potential of transmural care through telemonitoring for the first time in patients at risk for developing sepsis. By allowing for active follow-up of vital parameters in a transmural setting, this project aims to reduce the number of hospitalizations as compared to current practice. Furthermore, we aim to the number of patients referred to the emergency department after a visit at their primary care physician. Thereby, we aim to reduce the healthcare burden, yet providing the ability for rapid intervention in case of detarioration of patients, thereby reducing morbidity and mortality as well as associated costs.

Eligibility

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

Study details
    Sepsis
    Home Monitoring Follow-up
    Infection
    Innovativeness

NCT06920979

University Hospital, Antwerp

23 April 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.