Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06920979

Stop Sepsis Through Home Monitoring Cooperative

Led by University Hospital, Antwerp · Updated on 2026-05-01

120

Participants Needed

1

Research Sites

204 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Stop Sepsis Through Home Monitoring Cooperative

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older
  • Able to give informed consent
  • Presenting with signs of severe acute infection with risk of developing sepsis at emergency department or primary care physician
Not Eligible

You will not qualify if you...

  • Severely ill patients requiring immediate hospitalization (QSOFA 261, NEWS 265)
  • Patients with confusion, changes in mental state, or MMSE below 26
  • Presence of neuropenic fever
  • Patients undergoing immunosuppressive therapy or chemotherapy
  • Patients with HIV or AIDS
  • Suspicion of appendicitis, meningitis, meningeal irritation, or high risk of endocarditis
  • Complicated operation wounds at screening
  • Proven pneumonia (CURB 65 score 261)
  • Emphysema, COPD GOLD >1, or interstitial lung disease
  • Patients on home oxygen > 2 l/min chronically
  • Severe cardiovascular disease including severe heart failure NYHA class > 1, endoprosthesis, arrhythmias including atrial fibrillation, severe valve abnormalities, mechanical valve replacement, recent acute myocardial infarct or coronarography (less than 1 year), severe peripheral vascular disease
  • Acute chest pain suspicious for acute coronary pathology
  • Suspicion or chance of septic arthritis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Antwerp University Hospital (UZA)

Edegem, Antwerpen, Belgium, 2650

Actively Recruiting

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Research Team

C

Celine Maes, PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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