Evaluation of Immunoassay Measurements of Pancreatic Stone Protein Performed on abioSCOPE® Device With the PSP Assay on ICU Patients at Risk of Sepsis as an Aid in Identifying Sepsis

Study Overview
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Brief Summary
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This is a multicenter, prospective, biomarker-result-blinded observational study evaluating immunoassay measurements of pancreatic stone protein (PSP) performed on Abionic's abioSCOPE device with the PSP assay on ICU patients at risk of sepsis as an aid in identifying sepsis.

Official Title
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A Multicenter, Prospective, Biomarker-result-blinded Observational Study Evaluating Immunoassay Measurements of Pancreatic Stone Protein Performed on Abionic's abioSCOPE® Device With the PSP Assay on ICU Patients at Risk of Sepsis as an Aid in Identifying Sepsis

Conditions
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Sepsis

Intervention / Treatment
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* Device: Blood sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Provision and understanding of signed and dated written informed consent by patient or legally designated representative prior to any mandatory study-specific procedures, sample collection, or analysis. 2. Male or female, aged ≥ 18 years. 3. Admitted to ICU on the day of screening, with expectation that patient will require ICU management for a minimum of 24 hours. Exclusion Criteria: 1. Expected to die within 24 hours no matter what therapy is given, from the time of screening. 2. Suffering on ICU admission or study entry from or known acute or chronic pancreatitis or pancreatic cancer). 3. Admitted to ICU due to elective cardiac surgery with an uncomplicated stay anticipated. 4. Patients having a valid Do Not Resuscitate order. 5. Previous ICU admission during this hospital stay 6. Confirmed COVID-19 as reason for ICU admission

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Device: Blood sampling<br> | Device: Blood sampling<br>* Daily blood sample 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]).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability of the abioSCOPE PSP assay performed on day 1 of a participant's ICU admission to correctly identify those with sepsis. | Assess the clinical sensitivity and specificity of the abioSCOPE PSP assay obtained on day 1 of ICU stay to identify sepsis within 3 days, based on EIRC assessment of sepsis. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sepsis, Pancreatic Stone Protein, Point-of-care device, Immunoassay, Intensive care unit, Abionic