Serial Measurement of Pancreatic Stone Protein (PSP) for Sepsis Early Detection in ICU Patients

Serial Measurement of Pancreatic Stone Protein (PSP) for the Early Recognition and Diagnosis of Sepsis in Intensive Care Unit (ICU) Patients in China: A Multicenter, Prospective, Biomarker-result-blinded Observational Study

In this study, 250 patients with high-risk of sepsis will be enrolled, including ≥ 50 subjects with confirmed sepsis. Diagnostic criteria for sepsis should meet the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3), i.e., simultaneously meet the following two conditions: a) confirmed or suspected infection; b) the SOFA score has increased by ≥ 2 points compared with the baseline. Subjects who meet the inclusion criteria and do not meet the exclusion criteria will be collected 3 ml of peripheral venous blood samples daily (together with blood tests such as complete blood count for normal diagnosis and treatment purposes) until the diagnosis of sepsis or other diseases was confirmed.

During the blood collection period, relevant clinical information, laboratory examination results, treatment information and SOFA scores of the subjects will be collected. This study does not produce any intervention in the normal clinical diagnosis and treatment of the subjects. After the subjects were diagnosed with sepsis, a 28-day follow-up will be performed to record the number of days of ICU treatment and the survival of the subjects 7 and 28 days after the diagnosis of sepsis. If the subjects were diagnosed with septic shock during the follow-up period, they will be recorded as "Ds". If the subjects were still hospitalized in the study center, 3 ml of peripheral venous blood samples will be collected. The completion of the 28-day follow-up will be considered the end of the study.

This study aims to:

1. Comparing to reference method, the clinical diagnosis of sepsis (sepsis-3), and reference reagents, CE-marked IVD PSP capsule on the point-of-care abioSCOPE® device (Abionic SA), C-reactive protein (CRP) assay kit, procalcitonin (PCT) assay kit, etc., to verify and evaluate the comprehensive performance of PSP as a biomarker in the early recognition and diagnosis of sepsis manifesting within the first 3 days after testing. Diagnostic accuracy analysis [including sensitivity, specificity, positive predicted value, negative predicted value, positive likelihood ratio, negative likelihood ratio, area under ROC curve (AUC), etc.], and consistency analysis (including positive coincidence rate, negative coincidence rate, total coincidence rate, Kappa value, etc.) will be performed.

   1. The clinical performance of PSP for the diagnosis of sepsis will be evaluated based on the cross-sectional study data (on the day of confirmed visit).
   2. The clinical performance of PSP for recognition of sepsis manifesting within the first 3 days after testing will be evaluated based on the longitudinal study data (multiple visits data).

2. Comparing to the reference method and the reference reagent test results, try to use machine learning & deep learning methods to select a subset of relevant features (variable screening) from clinical information and biomarker data (CRP, PCT, IL-6, NT-proBNP, hs-cTnI, SAA, Cys C, CAL, etc.), to construct an innovative combined diagnostic model with PSP, "PSP+ X" model. The comprehensive performance of "PSP+X" model for the early recognition and diagnosis of sepsis manifesting within the first 3 days after testing will be evaluated. Diagnostic

   1. The clinical performance of "PSP+X" mode for the diagnosis of sepsis will be evaluated based on the cross-sectional study data (on the day of confirmed visit).
   2. The clinical performance of "PSP+X" mode for early recognition of sepsis manifesting within the first 3 days after testing will be evaluated based on the longitudinal study data (multiple visits data).

Study Overview

• Status: Completed
• Conditions: Adult Patients at High Risk of Sepsis
• Intervention / Treatment: Device: blood sampling

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Guangzhou Medical University
    • Shenzhen, Guangdong, China
      • Shenzhen Third People's Hospital
    • Zhuhai, Guangdong, China
      • Zhuhai People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

ICU admitted patients at high-risk of developing sepsis

Description

Inclusion Criteria:

1. ICU patients over 18 years old；

2. Patients at high risk of sepsis in any of the following:

   1. History of recent surgery or invasive medical procedures;
   2. Pneumonia, complicated urinary tract infections, abdominal infections, central nervous system infections, etc.;
   3. Severe trauma: such as the percentage of total body surface area (TBSA) burned > 15%, or serious traffic accident injuries, etc.;
3. Expected ICU stay for more than 4 days；
4. Have provided written informed consent or consent is given by the patient's legally designated representative.

Exclusion Criteria:

1. Patients diagnosed with sepsis;
2. Patients expected to die within 48 hours of admission to ICU；
3. Pregnancy；
4. Patient suffering from or known acute or chronic pancreatitis, pancreatic cancer or admitted after pancreatectomy; but if a patient develops any pancreatic disease during the ICU stay, he/she will remain in the study；
5. Patients with SOFA score < 2 but who have undergone blood purification;
6. Unable or unwilling to provide the required blood sample for testing；
7. Patients with unclear medical record information;
8. Patients with mental disorders and other disorders who cannot correctly understand informed consent;
9. Patients who subjectively refused to be enrolled in the study or who were judged not to be enrolled by the investigator.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Adult patients at high risk of sepsis presenting to Intensive Care Units (ICUs) and Emergency; Adult patients at high risk of sepsis presenting to Intensive Care Units (ICUs) and Emergency, who meet the inclusion criteria and do not meet the exclusion criteria will be enrolled in the trial and collected 3 ml of peripheral venous blood samples daily (together with blood tests such as complete blood count for normal diagnosis and treatment purposes) until the diagnosis of sepsis or other diseases was confirmed, for central analysis of biomarkers of inflammation, infection and/or sepsis, including but not limited to Pancreatic Stone Protein [① PSP (CLIA, Fapon Biotech); ② EU IVDR-marked IVD PSP capsule on the point-of-care abioSCOPE® device (Abionic SA)], C-reactive protein (CRP), Procalcitonin (PCT), etc.

Device: blood sampling; Subjects will be collected 3 ml of peripheral venous blood samples daily (together with blood tests such as complete blood count for normal diagnosis and treatment purposes) until the diagnosis of sepsis or other diseases was confirmed, for central analysis of biomarkers of inflammation, infection and/or sepsis, including but not limited to Pancreatic Stone Protein [① PSP (CLIA, Fapon Biotech); ② EU IVDR-marked IVD PSP capsule on the point-of-care abioSCOPE® device (Abionic SA)], C-reactive protein (CRP), Procalcitonin (PCT), Interleukin-6 (IL-6), Pro-Brain Natriuretic Peptide (pro-BNP), High-sensitivity cardiac troponin I (hs-cTnI), Serum amyloid A (SAA), Cystatin C (Cys C), Calprotectin (CAL), etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic performance of PSP to aid in the early recognition and diagnosis of sepsis manifesting within the first 3 days after testing	Comparing to reference method, the clinical diagnosis of sepsis (sepsis-3), and reference reagents, CE-marked IVD PSP capsule on the point-of-care abioSCOPE® device (Abionic SA), C-reactive protein (CRP) assay kit, procalcitonin (PCT) assay kit, etc., to verify and evaluate the comprehensive performance of PSP as a biomarker in the early recognition and diagnosis of sepsis in Chinese patient population manifesting within the first 3 days after testing. Diagnostic accuracy analysis and consistency analysis will be performed.	1) Blood sample collection period: from enrollment to the diagnosis of sepsis or other diseases was confirmed (≤ 7 days); 2) Follow-up period: after the diagnosis of sepsis, the subjects will be followed up for 28 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic performance of "PSP+X" model to aid in the early recognition and diagnosis of sepsis manifesting within the first 3 days after testing	Comparing to the reference method and the reference reagent test results, try to use machine learning & deep learning methods to select a subset of relevant features (variable screening) from clinical information and biomarker data (CRP, PCT, IL-6, NT-proBNP, hs-cTnI, SAA, Cys C, CAL, etc.), to construct an innovative combined diagnostic model (named it "PSP+X" index) with PSP by logistic regression. The receiver operating characteristic curve (ROC) analysis is used to evaluate the diagnostic value of "PSP+X" index for the early recognition and diagnosis of sepsis manifesting within the first 3 days after testing will be evaluated.	1) Blood sample collection period: from enrollment to the diagnosis of sepsis or other diseases was confirmed (≤ 7 days); 2) Follow-up period: after the diagnosis of sepsis, the subjects will be followed up for 28 days.

Collaborators and Investigators

• Sponsor: Fapon Biotech Inc.
• Collaborators: The First Affiliated Hospital of Guangzhou Medical University; Shenzhen People's Hospital; ZhuHai Hospital; Shenzhen Third People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2024
• Primary Completion (Actual): February 7, 2025
• Study Completion (Actual): March 31, 2025

Study Registration Dates

• First Submitted: September 28, 2025
• First Submitted That Met QC Criteria: November 15, 2025
• First Posted (Actual): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 15, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: Fapon-IIT-PSP-01; IIT-PSP-01 (Other Identifier: Fapon Biotech)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No