Early Diagnostic of Sepsis and Potential Impact on Antibiotic Management Based on Serial.Pancreatic Stone Protein (PSP) Measured Using the AbioScope.

A Multicenter, Device Clinical Study for the Early Diagnostic of Sepsis and Potential Impact on Antibiotic Management Based on Serial Pancreatic Stone Protein (PSP) Measured Using the AbioScope in Critically Ill Patients at High Risk of Sepsis.

The main purpose of this study is to compare the early detection of sepsis and the decision, by the Investigator to start or not, or to change, antibiotics in Intensive Care Unit (ICU) patients at high risk of sepsis, based on standard of care (clinical, laboratory and imaging data but not on PSP values), as well as timing of antibiotic de-escalation versus the the retrospective assessment (i.e., at the end of the study) of a First Endpoint Adjudication Committee (EAC) which is aware of the clinical data and of the PSP values but not of the Investigator's decision(s), and of the retrospective assessment of a Second Endpoint Adjudication Committee which is only aware of the PSP values.

This study will follow the site's routine clinical practice for the diagnostic, assessment and treatment of the enrolled patients, with the exception of daily blood samples 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 Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Device: Blood sampling

• Study Type: Observational
• Enrollment (Actual): 296

Contacts and Locations

Study Locations

• France
  • Le Mans, France, 72037
    • CH Le Mans, Service de Réanimation Médico Chirurgicale & USC
  • Limoges, France, 87042
    • CHU Limoges, Réanimation Polyvalente
  • Pierre-Bénite, France, 69495
    • CH Lyon-Sud, Services de soins critiques
  • Tours, France, 37044
    • Hôpital Bretonneau, CHU de Tours, Médecine Intensive - Réanimation
• Italy
  • Perugia, Italy, 6156
    • Ospedale Santa Maria della Misericordia, Terapia Intensiva
  • Ravenna, Italy, 48121
    • Ospedale Santa Maria delle Croci, Terapia Intensiva
  • Rimini, Italy, 47921
    • Ospedale Infermi, Dept Anesthesia and ICU
  • Torino, Italy, 10154
    • Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione
• Switzerland
  • Bern, Switzerland, 3010
    • Bern University Hospital, Universitätsklinik für Intensivmedizin
  • Geneva, Switzerland, 1205
    • Hopitaux Universitaires de Genève, Service des soins intensifs, Département APSI
  • Lausanne, Switzerland, 1011
    • Centre Hospitalier Universitaire Vaudois, Service of Adult Intensive Care
• United Kingdom
  • Guildford, United Kingdom, GU2 7XX
    • Royal Surrey County Hospital, Intensive Care Medicine
  • London, United Kingdom, NW1 2BU
    • University College London Hospitals, Anaesthetics Department
  • London, United Kingdom, SE1 7EH
    • Guy's & St Thomas' Hospital, Department of Critical Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients at high risk of sepsis admitted to the ICU.

Description

Inclusion Criteria:

1. Adult patients (age ≥ 18 years)
2. Requiring ICU management
3. At high risk of sepsis (septic patients are excluded)
4. Expected ICU stay for more than 4 days
5. Have provided written informed consent or consent is given by the patient's legally designated representative.

Exclusion Criteria:

1. Patient expected to die within 48 hours of admission to ICU
2. 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 IUC stay he/she will remain in the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the performance of serial PSP values measured using the AbioScope.	i) To assess the performance of serial PSP values measured using the AbioScope in the early detection of sepsis in ICU patients at high risk of developing sepsis.	Day 1 to Day 30, or until discharge from ICU

Collaborators and Investigators

• Sponsor: Abionic SA

Publications and helpful links

General Publications

• Pugin J, Daix T, Pagani JL, Morri D, Giacomucci A, Dequin PF, Guitton C, Que YA, Zani G, Brealey D, Lepape A, Creagh-Brown B, Wyncoll D, Silengo D, Irincheeva I, Girard L, Rebeaud F, Maerki I, Eggimann P, François B. Serial measurement of pancreatic stone protein for the early detection of sepsis in intensive care unit patients: a prospective multicentric study. Crit Care. 2021 Apr 20;25(1):151. doi: 10.1186/s13054-021-03576-8.

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2018
• Primary Completion (Actual): March 15, 2019
• Study Completion (Actual): March 15, 2019

Study Registration Dates

• First Submitted: March 16, 2018
• First Submitted That Met QC Criteria: March 16, 2018
• First Posted (Actual): March 23, 2018

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Sepsis, PSP, Abionic
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: AB-PSP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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