Clinical trial NCT06920979: Stop Sepsis Through Home Monitoring Cooperative
Official title: Stop Sepsis Through Home Monitoring Cooperative
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sepsis
Home Monitoring Follow-up
Infection
Innovativeness
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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 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

Primary outcomes:
measure: Evaluation of the development and roll out of a central medical center for monitoring at home
timeFrame: From enrollment to the end of monitoring depending on the clinical evolution of the patient, with a minimum of one week and a maximum follow-up of three weeks.
measure: Evaluation of the development and roll out of a central medical center for monitoring at home
timeFrame: From enrollment to the end of monitoring depending on the clinical evolution of the patient with a minimum follow-up of one week and up to a maximum of three weeks.
measure: Evaluation of the development and roll out of a central medical center for monitoring at home
timeFrame: From enrollment to the end of monitoring depending on the clinical evolution of the patient with a minimum follow-up of one week and up to a maximum of three weeks of follow-up.
measure: Evaluation of the development and roll out of a central medical center for monitoring at home
timeFrame: From enrollment to the end of monitoring depending on the clinical evolution of the patient with a minimum follow-up of one week and up to a maximum of three weeks of follow-up.
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital (UZA)
state: Antwerpen
Study officials:
References: