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

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ClinicalTrials.gov Identifier: NCT03474809
Recruitment Status : Completed
First Posted : March 23, 2018
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Abionic SA

Study Description
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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]).


Condition or disease Intervention/treatment
Sepsis Device: Blood sampling

Study Design
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Study Type : Observational
Actual Enrollment : 296 participants
Observational Model: Cohort
Time Perspective: Retrospective
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.
Actual Study Start Date : June 14, 2018
Actual Primary Completion Date : March 15, 2019
Actual Study Completion Date : March 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Groups and Cohorts
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Intervention Details:
  • Device: Blood sampling
    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]).

Outcome Measures
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Primary Outcome Measures :
  1. Assessment of the performance of serial PSP values measured using the AbioScope. [ Time Frame: Day 1 to Day 30, or until discharge from ICU ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill patients at high risk of sepsis admitted to the ICU.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03474809


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

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Responsible Party: Abionic SA
ClinicalTrials.gov Identifier: NCT03474809    
Other Study ID Numbers: AB-PSP-001
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abionic SA:
Sepsis, PSP, Abionic
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infections
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes