Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2020-03-26
2021-06-01
Brief Summary
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Detailed Description
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Clinical characteristics include: age, gender, co-morbidities, organ support therapies (mechanical ventilation, renal replacement therapy, extracorporeal membrane oxygenation, vasopressors), organ complications (pulmonary embolism, acute respiratory distress syndrome, renal failure, heart failure) and function, infective complications (ventilator associated pneumonia, central line associated bloodstream infection, pulmonary access, sepsis, septic shock), microbiologic and viral identification, 7-day and 28-day mortality.
Biological characteristics include:
* Admission workup: qualitative and quantitative Ig, ferritin, creatinine kinase, complement study (C3,C4,CH50),
* Daily workup: blood cells count, arterial blood gas analysis, lactate, electrolytes, albumin, blood urea nitrogen, creatinine, hemostasis (fibrinogen, factor V, II+VII, factor X, prothrombin time, antiXa activity, activated cephalin time, D-dimer), C-reactive protein, procalcitonin.
* Twice weekly workup: circulating cells phenotyping (T cell and subclass including Treg, B cell, Natural Killer cell, myeloid derived suppressor cell, neutrophils), interleukin 6.
* Bone marrow analysis when indicated by attending staff.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pediatric patients
All term children from birth to 18 years of age admitted in the PICU
No interventions assigned to this group
Adult patients
All patients \>18 years of age
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* No opposition from patients or legal representatives after study information
* Patients admitted to the pediatric intensive care unit of Bicêtre Hospital, Assistance Publique Hôpitaux de Paris - Paris Saclay University
* Between March 15, 2020 to June 31, 2021
Exclusion Criteria
ALL
No
Sponsors
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Bicetre Hospital
OTHER
Responsible Party
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Pierre Tissieres
Professor
Principal Investigators
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Pierre Tissieres, MD, DSc
Role: PRINCIPAL_INVESTIGATOR
Bicêtre Hospital
Locations
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Pediatric Intensive Care and Neonatal Medicine, Bicêtre Hospital, AP-HP PAris Saclay University
Le Kremlin-Bicêtre, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PS-PICRN--20001
Identifier Type: -
Identifier Source: org_study_id
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