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: Sepsis
• Interventions: Device: Blood sampling

• Registration Number: NCT04105699
• Lead Sponsor: Abionic SA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-25
• Study First Submitted QC: 2019-09-25
• Study First Posted: 2019-09-26
• Study Start: 2019-12-10
• Primary Completion: 2023-08-23
• Study Completion: 2023-12-28
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 544

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Device: Blood sampling	Blood sampling	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (5)

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