Clinical trial NCT03474809: Early Diagnostic of Sepsis and Potential Impact on Antibiotic Management Based on Serial.Pancreatic Stone Protein (PSP) Measured Using the AbioScope.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: Sepsis, PSP, Abionic
Lead sponsor: Abionic SA
Sponsor class: INDUSTRY
First posted: 2018-03-23
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients at high risk of sepsis admitted to the ICU.

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 \[PCT\]).


Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of the performance of serial PSP values measured using the AbioScope.
timeFrame: Day 1 to Day 30, or until discharge from ICU
Secondary outcomes:
Other outcomes:
Locations:
city: Le Mans
country: France
facility: CH Le Mans, Service de Réanimation Médico Chirurgicale & USC
city: Limoges
country: France
facility: CHU Limoges, Réanimation Polyvalente
city: Pierre-Bénite
country: France
facility: CH Lyon-Sud, Services de soins critiques
city: Tours
country: France
facility: Hôpital Bretonneau, CHU de Tours, Médecine Intensive - Réanimation
city: Perugia
country: Italy
facility: Ospedale Santa Maria della Misericordia, Terapia Intensiva
city: Ravenna
country: Italy
facility: Ospedale Santa Maria delle Croci, Terapia Intensiva
city: Rimini
country: Italy
facility: Ospedale Infermi, Dept Anesthesia and ICU
city: Torino
country: Italy
facility: Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione
city: Bern
country: Switzerland
facility: Bern University Hospital, Universitätsklinik für Intensivmedizin
city: Geneva
country: Switzerland
facility: Hopitaux Universitaires de Genève, Service des soins intensifs, Département APSI
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois, Service of Adult Intensive Care
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital, Intensive Care Medicine
city: London
country: United Kingdom
facility: University College London Hospitals, Anaesthetics Department
city: London
country: United Kingdom
facility: Guy's & St Thomas' Hospital, Department of Critical Care
Study officials:
References:
citation: 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.