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Recruiting NCT06920979

Stop Sepsis Through Home Monitoring Cooperative

No phase Interventional Sepsis Home Monitoring Follow-up Infection Innovativeness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: (semi)continue monitoring of patients at risk for sepsis at home.
Who it may be relevant to
Registry conditions: Sepsis, Home Monitoring Follow-up, Infection, Innovativeness. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Interventions

  • Other (semi)continue monitoring of patients at risk for sepsis at home
    (semi)continue monitoring of patients at risk for sepsis at home

Primary outcome measures

  • Evaluation of the development and roll out of a central medical center for monitoring at home [Time frame: 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.]
  • Evaluation of the development and roll out of a central medical center for monitoring at home [Time frame: 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.]
  • Evaluation of the development and roll out of a central medical center for monitoring at home [Time frame: 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.]
  • Evaluation of the development and roll out of a central medical center for monitoring at home [Time frame: 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.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Belgium · 1 center
  • Antwerp University Hospital (UZA) — Edegem

Identifiers

NCT: NCT06920979 · EDGE003963 · Governement Health Belgium

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗