NCT06920979 Stop Sepsis Through Home Monitoring Cooperative
| NCT ID | NCT06920979 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Antwerp |
| Condition | Sepsis |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-02-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06920979 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06920979 currently recruiting?
Yes, NCT06920979 is actively recruiting participants. Contact the research team at thuisopvolging@uza.be for enrollment information.
Where is the NCT06920979 trial being conducted?
This trial is being conducted at Edegem, Belgium.
Who is sponsoring the NCT06920979 clinical trial?
NCT06920979 is sponsored by University Hospital, Antwerp. The trial plans to enroll 120 participants.