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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Device: Blood sampling

• Study Type: Observational
• Enrollment (Actual): 544

Contacts and Locations

• Study Contact: Name: Iwan Märki, PhD; Phone Number: +41213533380; Email: iwan.maerki@abionic.com
• Study Contact Backup: Name: Soraya Hannane, MSc; Phone Number: +41213533380; Email: soraya.hannane@abionic.com

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Kentucky
    • Lexington, Kentucky, United States, 40513
      • University of Kentucky
  • Ohio
    • Toledo, Ohio, United States, 43608
      • Mercy Health St. Vincent
  • Rhode Island
    • Providence, Rhode Island, United States, 02904
      • Rhode Island Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

ICU admitted patients at risk of developing sepsis.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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]).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Abionic SA
• Collaborators: Avania

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2019
• Primary Completion (Actual): August 23, 2023
• Study Completion (Actual): December 28, 2023

Study Registration Dates

• First Submitted: September 25, 2019
• First Submitted That Met QC Criteria: September 25, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Intensive care unit; Sepsis; Immunoassay; Pancreatic Stone Protein; Point-of-care device; Abionic
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: AB-PSP-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No