NCT04105699

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
544

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

December 10, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2023

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

3.7 years

First QC Date

September 25, 2019

Last Update Submit

January 29, 2024

Conditions

Sepsis

Keywords

SepsisPancreatic Stone ProteinPoint-of-care deviceImmunoassayIntensive care unitAbionic

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Device: Blood sampling

Device: Blood sampling

Interventions

Blood samplingDEVICE

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 \[PCT\]).

Device: Blood sampling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ICU admitted patients at risk of developing sepsis.

You may qualify if:

  • \. 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.
  • \. Male or female, aged ≥ 18 years.
  • \. Admitted to ICU on the day of screening, with expectation that patient will require ICU management for a minimum of 24 hours.

You may not qualify if:

  • \. Expected to die within 24 hours no matter what therapy is given, from the time of screening.
  • \. Suffering on ICU admission or study entry from or known acute or chronic pancreatitis or pancreatic cancer).
  • \. Admitted to ICU due to elective cardiac surgery with an uncomplicated stay anticipated.
  • \. Patients having a valid Do Not Resuscitate order.
  • \. Previous ICU admission during this hospital stay
  • \. Confirmed COVID-19 as reason for ICU admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Kentucky

Lexington, Kentucky, 40513, United States

Location

Mercy Health St. Vincent

Toledo, Ohio, 43608, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02904, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

venous serum retained for future investigation related to sepsis biomarkers

MeSH Terms

Conditions

Sepsis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2019

First Posted

September 26, 2019

Study Start

December 10, 2019

Primary Completion

August 23, 2023

Study Completion

December 28, 2023

Last Updated

January 30, 2024

Record last verified: 2024-01

Locations

US(5)