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

Completed

Conditions studied: Sepsis

In brief

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.

Key facts

Study ID

NCT04105699

Run by

Abionic SA

People needed

544

Starts

2019-12-10

Expected to finish

2023-12-28

Last updated by the study team

2024-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Northwestern University — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Kentucky — Lexington, Kentucky, United States
• Mercy Health St. Vincent — Toledo, Ohio, United States
• Rhode Island Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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