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

NCT03474809 | Completed

• 1 other identifier: AB-PSP-001
• Study Type: observational
• Target: 296
• Locations: 4 countries
• Sites: 14

Brief Summary

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 \[PCT\]).

Conditions

Sepsis

Keywords

Sepsis, PSP, Abionic

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Blood sampling DEVICE

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 \[PCT\]).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Patient expected to die within 48 hours of admission to ICU
• 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.

Sponsors & Collaborators

• Abionic SA: lead

Study Sites (14)

CH Le Mans, Service de Réanimation Médico Chirurgicale & USC

Le Mans, 72037, France

Location

CHU Limoges, Réanimation Polyvalente

Limoges, 87042, France

Location

CH Lyon-Sud, Services de soins critiques

Pierre-Bénite, 69495, France

Location

Hôpital Bretonneau, CHU de Tours, Médecine Intensive - Réanimation

Tours, 37044, France

Location

Ospedale Santa Maria della Misericordia, Terapia Intensiva

Perugia, 6156, Italy

Location

Ospedale Santa Maria delle Croci, Terapia Intensiva

Ravenna, 48121, Italy

Location

Ospedale Infermi, Dept Anesthesia and ICU

Rimini, 47921, Italy

Location

Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione

Torino, 10154, Italy

Location

Bern University Hospital, Universitätsklinik für Intensivmedizin

Bern, 3010, Switzerland

Location

Hopitaux Universitaires de Genève, Service des soins intensifs, Département APSI

Geneva, 1205, Switzerland

Location

Centre Hospitalier Universitaire Vaudois, Service of Adult Intensive Care

Lausanne, 1011, Switzerland

Location

Royal Surrey County Hospital, Intensive Care Medicine

Guildford, GU2 7XX, United Kingdom

Location

University College London Hospitals, Anaesthetics Department

London, NW1 2BU, United Kingdom

Location

Guy's & St Thomas' Hospital, Department of Critical Care

London, SE1 7EH, United Kingdom

Location

Related Publications (1)

• 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, Francois 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.

  PMID: 33879189 DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: March 23, 2018
• Study Start: June 14, 2018
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

FR (4); CH (3); IT (4); GB (3)