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New treatment option for Sepsis
Official title Stop Sepsis Through Home Monitoring Cooperative
ClinicalTrials.gov ID: NCT06920979
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- This study will include patients aged 18 years or older, capable of giving informed consent, presenting with signs of severe acute infection with a...
You likely can't join if
- Patients that are severely ill and require immediate hospitalization Qucik Sepsis Related Organ Failure score (QSOFA) ≥ 1 National Early Warning...
- 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
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Edegem, Antwerpen, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edegem, Antwerpen, Belgium. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.