Study of Immunosuppression Biomarkers Acquired in Patients Hospitalized in Intensive Care Unit

Study Overview
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Brief Summary
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Open-label, non-randomized, prospective, single center, observational, translational study

Detailed Description
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The aim of this trial is to study immunosuppression biomarkers in patients hospitalized in intensive care unit in comparison to non-septic patients. Prevalence of immunosuppression acquired in intensive care unit will be studied and patients most likely to develop nosocomial infection will be early identified

Official Title
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Study of Immunosuppression Biomarkers Acquired in Patients Hospitalized in Intensive Care Unit

Conditions
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Patient Hospitalized in Intensive Care Unit

Intervention / Treatment
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* Other: blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient older than 18 years old Patient hospitalized in intensive care unit for any reason Patient with infection started less than 5 days before admission Patient with mechanical ventilation or not Patient with arterial catheter for an invasive monitoring of blood pressure Patient informed about the study protocol and approved to participate. Patients hospitalized for a severe bacterial infection (severe sepsis or septic shock) Patient hospitalized for a non-infectious disease Exclusion Criteria: Pregnancy Advanced immunosuppression defined by proved humoral or cellular impairment by continuous administration of steroids at any dose since more than one month before hospitalization, transplantation, radiotherapy or chemotherapy in the preceding year Initiation of an immunosuppressive therapy as chemotherapy, cyclophosphamide or high dose corticotherapy (>0.5mg/kg/day)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient with sepsis<br>Patient hospitalized in intensive care unit | Other: blood sample<br> <br> |
| Patient without sepsis<br>Patient hospitalized in intensive care unit | Other: blood sample<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of immunosuppression biomarkers in septic and non-septic patients hospitalized in intensive care unit |  | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of immunosuppression biomarkers with occurrence of events reflecting a clinical immunosuppression | Study of CMV reactivation and nosocomial infections | Day 14 | 
| Association of immunosuppression biomarkers with patients demographic data | Record of patient age and gender | Day 14 | 
| Association of immunosuppression biomarkers with patients clinical data | Record of severity score, duration of hospitalization, duration of mechanical ventilation, morbidity | Day 14 |