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

Abionic

Status: Completed

Conditions: Sepsis

Treatments: Device: Blood sampling

Study type: Observational

Funder types: Industry

Identifiers

NCT04105699

AB-PSP-002

Details and patient eligibility

About

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.

Enrollment: 544 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

544 participants in 1 patient group

Device: Blood sampling

Treatment:

Device: Blood sampling