Study of Platelet Activation in Septic Shock Patients

Study Overview
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Brief Summary
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Some studies have shown that antiplatelets agents could reduce organ dysfunction in septic shock in mice and human models. Platelets are actors in immunity and their activation can be complicated by tissue damage with vascular occlusions which can lead to organ dysfunction. Investigators can hypothesize an increase in platelet activation and in leukocyte-platelet aggregates in septic shock.

Official Title
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Study of Platelet Activation in Septic Shock Patients

Conditions
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Septic Shock

Intervention / Treatment
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* Other: Septic choc group
* Other: Orthopedic surgery group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: EXPERIMENTAL GROUP Patient who possibly gave an oral agreement to inclusion and may sign a consent once out of intensive care Patients hospitalized in general intensive care Patient hospitalized for less than 72 hours Patient suffering from severe sepsis, whatever their origin, with hypotension (PAs <90mmHg) despite adequate fluid resuscitation and vasoactive requiring the use of amines, with hypoperfusion and / or at least one organ dysfunction ( septic shock) Patient with a Sequential Organ Failure Assessment (SOFA) score> 8 (or> 2 in an organ) in the first 24 hours Patient enjoying a social security scheme or equivalent CONTROL GROUP Signed informed consent Patient seen anesthesia consultation for orthopedic knee prosthesis of laying or hip with a negative balance infectious Patient enjoying a social security scheme or equivalent Exclusion Criteria: EXPERIMENTAL GROUP Patient on safeguarding justice, guardianship Patient suffering from a haematological malignancy (leukemia, lymphoma ...) Patient suffering from thrombocytopenia or constitutional thrombopathy Pregnant CONTROL GROUP Patient on safeguarding justice, guardianship Patient with infectious positive balance (dental, urinary tract) prior to surgery Patient suffering from a haematological malignancy (leukemia, lymphoma ...) Patient suffering from thrombocytopenia or constitutional thrombopathy Pregnant

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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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>The test group (Septic choc group) includes 15 patients suffering from septic shock in intensive care unit. | Other: Septic choc group<br>* Specific platelet activation markers, circulating leukocyte-platelet aggregates will be assessed in peripheral venous blood at the admission in intensive care unit and 48 hours later for leukocyte-platelet aggregates measurements.<br>|
| Other: Control group<br>The control group (Orthopedic surgery group) includes 15 patients recruited from the orthopedic surgical anesthesia consultation programmed for a prosthetic hip or knee pose. | Other: Orthopedic surgery group<br>* Specific platelet activation markers, circulating leukocyte-platelet aggregates will be assessed in peripheral venous blood during the orthopedic surgical anesthesia consultation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of platelets activation markers expression (CD62-P, antibody CD63, CD42b) | Specific platelet activation markers and circulating leukocyte-platelet aggregates will be assessed in peripheral venous blood at the admission in intensive care unit for patients in test group and during the orthopedic surgical anesthesia consultation for patients in control group. | T0 at the admission in intensive care unit | 
| Level of platelets activation markers expression (CD62-P, CD63, CD42b) | Specific platelet activation markers and circulating leukocyte-platelet aggregates will be assessed in peripheral venous blood 48 hours later admission in intensive care unit only for patients in test group. | T48 hours after admission in intensive care unit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of leukocyte-platelet aggregates |  | T0 at the admission in intensive care unit | 
| Kinetics of leukocyte-platelet aggregates formation |  | T0 at the admission in intensive care unit | 
| Correlation of leukocyte-platelet aggregates rate and septic shock severity. |  | T0 at the admission in intensive care unit | 
| Comparison of platelet activation in subjects treated or not with antiplatelet agents. |  | T0 at the admission in intensive care unit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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leukocyte and platelet aggregates, platelet activation