SepsisNCT04105699
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
An observational study of Sepsis, run by Abionic SA at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Blood sampling
- Type of treatment
- Medical device
- How many people
- 544 participants
- Where
- 5 sitesUnited States
- Study dates
- 10 Dec 2019to 28 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU admitted patients at risk of developing sepsis.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Northwestern University
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
University of Kentucky
Lexington, Kentucky, 40513
Rhode Island Hospital
Providence, Rhode Island, 02904
Mercy Health St. Vincent
Toledo, Ohio, 43608
About this study
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
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.
- Conditions
- Sepsis
- Being tested
- Blood sampling
- Keywords
- Sepsis, Pancreatic Stone Protein, Point-of-care device, Immunoassay, Intensive care unit, Abionic
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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]).
| Study group | Role | What they receive |
|---|---|---|
| Device: Blood sampling | Not described Receives: Device: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start10 Dec 2019
- Primary completion23 Aug 2023
- Study completion28 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 544 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abionic SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105699
- Sponsor's protocol ID
- AB-PSP-002
- Status last verified
- Jan 2024
- First submitted
- 25 Sep 2019
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Shorr AF, Kollef MH, Wunderink RG, Jauregui-Peredo LE, Bernard AC, Kim HK, Balk RA, Cristofaro P, Levy MM. Diagnostic Performance of Point-of-Care Immunoassay Measurements of Pancreatic Stone Protein for Sepsis Detection in ICU Patients: A Prospective, Multicenter, Biomarker-Blinded Study. Crit Care Med. 2026 May 1;54(5):1147-1157. doi: 10.1097/CCM.0000000000007087. Epub 2026 Mar 4.
PubMed 41778855
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04105699
- Acronym / sponsor ID
- AB-PSP-002
- Conditions
- Sepsis
- Keywords
- Sepsis, Pancreatic Stone Protein, Point-of-care device, Immunoassay, Intensive care unit, Abionic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 544 participants (actual)
- Lead sponsor
- Abionic SAIndustry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 28 Dec 2023 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device: Blood sampling | – | Device: Blood sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU admitted patients at risk of developing sepsis.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingDaily 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 | Device: Blood sampling |
Primary outcome
Ability of the abioSCOPE PSP assay performed on day 1 of a participant's ICU admission to correctly identify those with sepsis.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Derived from this study: PubMed 41778855Shorr AF, Kollef MH, Wunderink RG, Jauregui-Peredo LE, Bernard AC, Kim HK, Balk RA, Cristofaro P, Levy MM. Diagnostic Performance of Point-of-Care Immunoassay Measurements of Pancreatic Stone Protein for Sepsis Detection in ICU Patients: A Prospective, Multicenter, Biomarker-Blinded Study. Crit Care Med. 2026 May 1;54(5):1147-1157. doi: 10.1097/CCM.0000000000007087. Epub 2026 Mar 4.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Abionic SA at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of the abioSCOPE PSP assay performed on day 1 of a participant's ICU admission to correctly identify those with sepsis. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04105699, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.