Study of Platelet Activation in Septic Shock Patients

Not Applicable

Completed

• Conditions: Septic Shock
• Interventions: Other: Orthopedic surgery group; Other: Septic choc group

• Registration Number: NCT02635854
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-14
• Study First Submitted QC: 2015-12-18
• Study First Posted: 2015-12-21
• Study Start: 2016-03
• Primary Completion: 2017-01
• Study Completion: 2017-01-05
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-13
• Last Update Posted: 2018-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Orthopedic surgery group	The control group (Orthopedic surgery group) includes 15 patients recruited from the orthopedic surgical anesthesia consultation programmed for a prosthetic hip or knee pose.
Test group	Septic choc group	The test group (Septic choc group) includes 15 patients suffering from septic shock in intensive care unit.

Primary Outcome Measures

Name	Time	Method
Level of platelets activation markers expression (CD62-P, antibody CD63, CD42b)	T0 at the admission in intensive care unit	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.
Level of platelets activation markers expression (CD62-P, CD63, CD42b)	T48 hours after admission in intensive care unit	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.

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

CHU Toulouse; 🇫🇷 Toulouse, France