Septic Shock
Conditions
Brief summary
Sepsis induces hemostatic disorders due to the exessive or inappropriate activation of inflammation, which could lead either to hypercoagulability or hypocoagulability. It is currently not possible to determine the hemostatic status of a given patient. This instability of hemostatic system is not revealed by classical tests. Thus, a better characterization of hemostatic status could certainly improve patient care. This study aims at characterizing disorders of coagulation and fibrinolysis using global tests such as thrombin generation test or coagulolytic test. Furthermore, the association with biological markers of interest (such as microparticles, neutrophil elastase or histones) will be evaluated.
Interventions
BIOLOGICALblood sampling
additional blood sampling (volume: 18 mL)
Sponsors
Diagnostica Stago
Central Hospital, Nancy, France
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligibility criteria for patients with septic schock Inclusion Criteria: * septic shock (Dellinger, 2013) * age \>18y * hospitalized patients * signature of an informed consent (emergency consent) * affiliation to a social security regimen
Exclusion criteria
* pregnancy or breast-feeding women * moribund patient * oral anticoagulant therapy * thrombophilia * Minor patients * Patients under tutelage Eligibility criteria from subject without septic shock Subject blood samples without septic shock are collected from a historical healthy volunteers cohort.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in endogenous thrombin potential as assessed by thrombin generation test | 48 hours | thrombin generation will be measured using CAT method (fluorescence) in plasma from patients within 48 hours. Endogenous thrombin potential is defined as the area under the thrombin generation curve and will be compared with values obtained in healthy subjects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Thrombin peak as assessed by thrombin generation test | 48 hours | thrombin generation will be measured using CAT method (fluorescence) in plasma from patients within 48 hours. Thrombin peak is defined as the highest thrombin concentration derived from the thrombin generation curve and will be compared with values obtained in healthy subjects. |
| Changes in clot lysis time as assessed by clot lysis assay | 48 hours | Clot lysis assay will, be performed in plasma from patients and will be compared with those obtained in healthy subjects. |
| Correlation of neutrophil elastase with changes in endogenous thrombin potential | 48 hours | Neutrophil elastase will be measured in plasma from patients. |
| Correlation of cell-derived microparticles with changes in endogenous thrombin potential | 48 hours | microparticles derived from leukocytes, erythrocytes, platelets and endothelial cells will be measured in plasma from patients by flow cytometry. |
| Correlation of circulating histones with changes in endogenous thrombin potential | 48 hours | Circulating histones will be measured in plasma from patients |
Contacts
Primary ContactBruno MI LEVY, PhD
Outcome results
None listed