Clinical trial NCT02635854: Study of Platelet Activation in Septic Shock Patients
Official title: Study of Platelet Activation in Septic Shock Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Keywords: leukocyte and platelet aggregates
platelet activation
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2015-12-21
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Level of platelets activation markers expression (CD62-P, antibody CD63, CD42b)
timeFrame: T0 at the admission in intensive care unit
measure: Level of platelets activation markers expression (CD62-P, CD63, CD42b)
timeFrame: T48 hours after admission in intensive care unit
Secondary outcomes:
measure: Rate of leukocyte-platelet aggregates
timeFrame: T0 at the admission in intensive care unit
measure: Kinetics of leukocyte-platelet aggregates formation
timeFrame: T0 at the admission in intensive care unit
measure: Correlation of leukocyte-platelet aggregates rate and septic shock severity.
timeFrame: T0 at the admission in intensive care unit
measure: Comparison of platelet activation in subjects treated or not with antiplatelet agents.
timeFrame: T0 at the admission in intensive care unit
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: CHU Toulouse
name: Fanny BOUNES, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Valerio-Rojas JC, Jaffer IJ, Kor DJ, Gajic O, Cartin-Ceba R. Outcomes of severe sepsis and septic shock patients on chronic antiplatelet treatment: a historical cohort study. Crit Care Res Pract. 2013;2013:782573. doi: 10.1155/2013/782573. Epub 2013 Feb 20.
citation: Rahman M, Gustafsson D, Wang Y, Thorlacius H, Braun OO. Ticagrelor reduces neutrophil recruitment and lung damage in abdominal sepsis. Platelets. 2014;25(4):257-63. doi: 10.3109/09537104.2013.809520. Epub 2013 Jul 15.
citation: Li Z, Yang F, Dunn S, Gross AK, Smyth SS. Platelets as immune mediators: their role in host defense responses and sepsis. Thromb Res. 2011 Mar;127(3):184-8. doi: 10.1016/j.thromres.2010.10.010. Epub 2010 Nov 13.