Study of Platelet Activation in Septic Shock Patients (PASS)

Toulouse University Hospital

Status: Completed

Conditions: Septic Shock

Treatments: Other: Septic choc group; Other: Orthopedic surgery group

Study type: Interventional

Funder types: Other

Identifiers

NCT02635854

RC31/15/7738

15 7738 02 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Test group

Experimental group

Description:

The test group (Septic choc group) includes 15 patients suffering from septic shock in intensive care unit.

Treatment:

Other: Septic choc group

Control group

Other group

Description:

The control group (Orthopedic surgery group) includes 15 patients recruited from the orthopedic surgical anesthesia consultation programmed for a prosthetic hip or knee pose.

Treatment:

Other: Orthopedic surgery group