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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Device: Blood sampling
  • Device: Blood sampling
    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]).

Recruiting Locations

More Details

NCT ID
NCT04105699
Status
Completed
Sponsor
Abionic SA

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.