Status:
RECRUITING
Stop Sepsis Through Home Monitoring Cooperative
Lead Sponsor:
University Hospital, Antwerp
Conditions:
Sepsis
Home Monitoring Follow-up
Eligibility:
All Genders
18+ years
Phase:
NA
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06920979
Start Date
February 1 2025
End Date
December 31 2025
Last Update
April 10 2025
Active Locations (1)
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1
Antwerp University Hospital (UZA)
Edegem, Antwerpen, Belgium, 2650