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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04105699
• Other study ID #: AB-PSP-002
• Status: Completed
• Start date: December 10, 2019
• Est. completion date: December 28, 2023

Study information

• Verified date: January 2024
• Source: Abionic SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 544
• Est. completion date: December 28, 2023
• Est. primary completion date: August 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

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]).

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Kentucky	Lexington	Kentucky
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Mercy Health St. Vincent	Toledo	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Abionic SA	Avania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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