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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03474809 |
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Date of registration:
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16/03/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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. |
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Date of first enrolment:
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June 14, 2018 |
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Target sample size:
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296 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03474809 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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France
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Italy
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Switzerland
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United Kingdom
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Sepsis
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Intervention(s)
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Device: Blood sampling
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Primary Outcome(s)
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Assessment of the performance of serial PSP values measured using the AbioScope.
[Time Frame: Day 1 to Day 30, or until discharge from ICU]
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Secondary ID(s)
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AB-PSP-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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