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Status:

COMPLETED

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

Lead Sponsor:

Abionic SA

Collaborating Sponsors:

Avania

Conditions:

Sepsis

Eligibility:

All Genders

18+ years

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 10 2019

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 28 2023

Estimated Enrollment :

544 Patients enrolled

Trial Details

Trial ID

NCT04105699

Start Date

December 10 2019

End Date

December 28 2023

Last Update

January 30 2024

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Northwestern University

Chicago, Illinois, United States, 60611

2

Rush University Medical Center

Chicago, Illinois, United States, 60612

3

University of Kentucky

Lexington, Kentucky, United States, 40513

4

Mercy Health St. Vincent

Toledo, Ohio, United States, 43608