An observational study in Septic Shock, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-26.
Sponsored by University Hospital, Bordeaux · Observational
Blood platelets play a major role in the inflammatory response. A dysregulation of platelets activation may be one of the contributors to tissue damage in critically ill patients with septic shock. The main objective of this study is to compare platelet activation markers levels (including plasma concentration in CD154, beta thromboglobulin, platelet factor 4, platelet microparticles, soluble CD62, RANTES, GRO-alpha and HMGB-1) at the early phase of a septic shock and a systemic inflammatory response syndrome (SIRS).
Sepsis is defined as life-threatening organ dysfunction due to dysregulated host response to infection which can lead to many failures of vital organs (kidneys, lungs, liver) in critically ill patients. It is accompanied at an early phase by both a proinflammatory and procoagulant state generating many platelet activators. Given their essential role in the inflammatory response, a dysregulation of platelets activation may be one of the contributors to tissue damage. To determine if platelet activation contribute to deregulation of the inflammatory response of the host in sepsis, the main objective of this study is to compare platelet activation markers levels of patients with septic shock and after major surgery. Plasma concentration in CD154, beta thromboglobulin, platelet factor 4, platelet microparticles, soluble CD62, RANTES, GRO-alpha, HMGB-1, monocyte Dnases signal, circulating free DNA and DNase1 and DNase1L3 activities will be studied and compared at inclusion (Day 0), Day 1 and Day 5.
862 studies on the registry are indexed under Shock, Septic; 207 are open to participants now.
This study's enrollment of 202 is above the median of 100 across 298 observational studies indexed under Shock, Septic.
Browse Shock, Septic studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
In this study, two populations will be recruiting, patients presenting a septic shock and patient presenting a SIRS, who will be admitted in intensive care unit or in continuing care units.
Patients aged over 18 years admitted to an intensive care unit for:
Exclusion Criteria:
Plasma of 100 patients presenting a septic shock will be analysed including plasma concentration in CD154, beta thromboglobulin, platelet factor 4, platelet microparticles, soluble CD62, RANTES, GRO-alpha and HMGB-1
Other: Septic shock
Plasma of 100 patient presenting a systemic inflammatory response syndrome = SIRS will be analysed including plasma concentration in CD154, beta thromboglobulin, platelet factor 4, platelet microparticles, soluble CD62, RANTES, GRO-alpha and HMGB-1
Other: Systemic Inflammatory Response Syndrome
Plasma concentration in CD154, beta thromboglobulin, platelet factor 4, platelet microparticles, soluble CD62, RANTES, GRO-alpha, HMGB-1, monocyte Dnases signal, circulating free DNA and DNase1 and DNase1L3 activities will be studied and compared at inclusion (Day 0), Day 1 and Day 5.
Plasma concentration in CD154, beta thromboglobulin, platelet factor 4, platelet microparticles, soluble CD62, RANTES, GRO-alpha, HMGB-1, monocyte Dnases signal, circulating free DNA and DNase1 and DNase1L3 activities will be studied and compared at inclusion (Day 0), Day 1 and Day 5.
Plasma concentration
Plasma concentration in CD154, beta thromboglobulin, platelet factor 4, platelet microparticles, soluble CD62, RANTES, GRO-alpha and HMGB-1 will be measured in each group by dosage
Time frame: Day 0, day 1 and day 5
Neutrophil Extracellular Traps formation
Monocyte Dnases signal, circulating free DNA and DNase1 and DNase1L3 activities will be measured in each group by dosage
Time frame: Day 0, day 1 and day 5
Markers of platelet activation and severity of organ failure
Correlation between markers of platelet activation and severity of organ failure will be measured by Sequential Organ Failure Assessment (SOFA) score. The score varies from 0 to 4.
Time frame: Day 0 and Day 7
Markers of platelet activation and inflammatory markers
Correlation between markers of platelet activation and inflammatory markers (leukocytes and CRP) will be measured by KDIGO score.The score varies from 1 to 4.
Time frame: Day 0 and Day 7
Markers of platelet activation and ISTH score
Correlation between markers of platelet activation and ISTH score of the International Society of Thrombosis and Haemostasis (ISTH) will be measured by Coagulation Intra Vasculaire Disséminée score. The score varies from \< 5 to ≥ 5 : If score ≥ 5: compatible with a CIVD patent. If score \<5: suggests a latent DIC.
Time frame: Day 0
Markers of platelet activation and platelet count
Correlation between markers of platelet activation (CD154, beta thromboglobulin, platelet factor 4, platelet microparticles, soluble CD62, RANTES, GRO-alpha and HMGB-1) and platelet count.
Time frame: Day 0 and day 7
Markers of platelet activation on ICU mortality
Prognostic aspect of markers of platelet activation (CD154, beta thromboglobulin, platelet factor 4, platelet microparticles, soluble CD62, RANTES, GRO-alpha and HMGB-1) on ICU mortality, hospital mortality, ICU and hospital length of stay, norepinephrine, kidney failure and ventilation free days.
Time frame: Day 0 and Day 7
Levels of platelet activation markers
Correlation between levels of platelet activation markers studied (CD154, beta thromboglobulin, platelet factor 4, platelet microparticles, soluble CD62, RANTES, GRO-alpha and HMGB-1).
Time frame: Day 0 and Day 7
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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University Hospital, Bordeaux