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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04105699

Enrollment

544

Registered

2019-09-26

Start date

2019-12-10

Completion date

2023-12-28

Last updated

2024-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Keywords

Sepsis, Pancreatic Stone Protein, Point-of-care device, Immunoassay, Intensive care unit, Abionic

Brief summary

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.

Interventions

DEVICEBlood 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 \[PCT\]).

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Ability of the abioSCOPE PSP assay performed on day 1 of a participant's ICU admission to correctly identify those with sepsis.	Day 1	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026