A Multicenter, Device Clinical Study for the Early Diagnostic of Sepsis and Potential Impact on Antibiotic Management Based on Serial Pancreatic Stone Protein (PSP) Measured Using the AbioScope in Critically Ill Patients at High Risk of Sepsis.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abionic SA
- Enrollment
- 296
- Locations
- 14
- Primary Endpoint
- Assessment of the performance of serial PSP values measured using the AbioScope.
Study Overview
Brief Summary
The main purpose of this study is to compare the early detection of sepsis and the decision, by the Investigator to start or not, or to change, antibiotics in Intensive Care Unit (ICU) patients at high risk of sepsis, based on standard of care (clinical, laboratory and imaging data but not on PSP values), as well as timing of antibiotic de-escalation versus the the retrospective assessment (i.e., at the end of the study) of a First Endpoint Adjudication Committee (EAC) which is aware of the clinical data and of the PSP values but not of the Investigator's decision(s), and of the retrospective assessment of a Second Endpoint Adjudication Committee which is only aware of the PSP values.
This study will follow the site's routine clinical practice for the diagnostic, assessment and treatment of the enrolled patients, with the exception of daily blood samples which will be taken for the PSP measurement using the AbioScope as well as another daily sample taken for central analysis of biomarkers of inflammation, infection and/or sepsis (including but not limited to C-reactive protein [CRP] and Procalcitonin [PCT]).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients (age ≥ 18 years)
- •Requiring ICU management
- •At high risk of sepsis (septic patients are excluded)
- •Expected ICU stay for more than 4 days
- •Have provided written informed consent or consent is given by the patient's legally designated representative.
Exclusion Criteria
- •Patient expected to die within 48 hours of admission to ICU
- •Patient suffering from or known acute or chronic pancreatitis, pancreatic cancer or admitted after pancreatectomy, but if a patient develops any pancreatic disease during the IUC stay he/she will remain in the study.
Outcomes
Primary Outcomes
Assessment of the performance of serial PSP values measured using the AbioScope.
Time Frame: Day 1 to Day 30, or until discharge from ICU
i) To assess the performance of serial PSP values measured using the AbioScope in the early detection of sepsis in ICU patients at high risk of developing sepsis.
Secondary Outcomes
No secondary outcomes reported