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
Pro-inflammatory Role of Blood Platelets in Critically Ill Patients With Septic Shock.
Brief Summary
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).
Intervention / Treatment
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Septic shock (OTHER)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.
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Systemic Inflammatory Response Syndrome (OTHER)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.
Condition or Disease
- Septic Shock
Phase
Study Design
| Study type: | OBSERVATIONAL |
|---|---|
| Status: | Recruiting |
| Study results: | No Results Available |
| Enrollment: | 200 (ESTIMATED) |
| Time Perspective: | Prospective |
| Observational Model: | Cohort |
Masking |
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Clinical Trial Dates
| Start date: | Nov 09, 2020 | ACTUAL |
|---|---|---|
| Primary Completion: | Feb 01, 2024 | ESTIMATED |
| Completion Date: | Feb 01, 2024 | ESTIMATED |
| Study First Posted: | Sep 06, 2019 | ACTUAL |
| Last Updated: | Jul 18, 2023 |
Sponsors / Collaborators
Lead Sponsor:
University Hospital, Bordeaux
Lead sponsor is responsible party
Responsible Party:
N/A
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.
Participant Groups
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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
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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
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
* Patients aged over 18 years admitted to an intensive care unit for:
* a septic shock evolving for less than 24h (defined by an increase in the SOFA (Sequential Organ Failure Assessment) score of at least 2 points related to an infection, a persisting hypotension requiring vasopressors to maintain MAP ≥65 mmHg and a serum lactate level \>2 mmol/L (18 mg/dL) despite adequate volume resuscitation)
* Or a systemic inflammatory response syndrome (SIRS) evolving for less than 24h (defined as 2 or more of the following variables: fever of more than 38°C or less than 36°C, heart rate of more than 90 beats per minute, respiratory rate of more than 20 breaths per minute or arterial carbon dioxide tension (PaCO2) of less than 32 mm Hg, abnormal white blood cell count (\>12,000/µL or \<4,000/µL or \>10% immature forms).
Exclusion Criteria:
* Age \< 18 years
* Known history of constitutional thrombopathy (Bernard Soulier's disease, Glanzmann thrombasthenia, Gray's syndrome or dense granule disease)
* Myeloproliferative or myelodysplastic syndrome
* Autoimmune thrombocytopenic purpura
* Acute leukemia
* Haemorrhagic shock
* Platelet transfusion within 7 days prior to inclusion
* Antiplatelet medication (clopidogrel or ticagrelor taken within 5 days of inclusion, prasugrel or dipyridamole within 7 days of inclusion)
* Active HIV infection or known active hepatitis B or C
* Pregnant or breastfeeding woman
* Patients protected by the law, under guardianship or trusteeship, or deprived of liberty
* Patients without health insurance
* Patients aged over 18 years admitted to an intensive care unit for:
* a septic shock evolving for less than 24h (defined by an increase in the SOFA (Sequential Organ Failure Assessment) score of at least 2 points related to an infection, a persisting hypotension requiring vasopressors to maintain MAP ≥65 mmHg and a serum lactate level \>2 mmol/L (18 mg/dL) despite adequate volume resuscitation)
* Or a systemic inflammatory response syndrome (SIRS) evolving for less than 24h (defined as 2 or more of the following variables: fever of more than 38°C or less than 36°C, heart rate of more than 90 beats per minute, respiratory rate of more than 20 breaths per minute or arterial carbon dioxide tension (PaCO2) of less than 32 mm Hg, abnormal white blood cell count (\>12,000/µL or \<4,000/µL or \>10% immature forms).
Exclusion Criteria:
* Age \< 18 years
* Known history of constitutional thrombopathy (Bernard Soulier's disease, Glanzmann thrombasthenia, Gray's syndrome or dense granule disease)
* Myeloproliferative or myelodysplastic syndrome
* Autoimmune thrombocytopenic purpura
* Acute leukemia
* Haemorrhagic shock
* Platelet transfusion within 7 days prior to inclusion
* Antiplatelet medication (clopidogrel or ticagrelor taken within 5 days of inclusion, prasugrel or dipyridamole within 7 days of inclusion)
* Active HIV infection or known active hepatitis B or C
* Pregnant or breastfeeding woman
* Patients protected by the law, under guardianship or trusteeship, or deprived of liberty
* Patients without health insurance
This clinical trial is recruiting
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Primary Outcomes
Secondary Outcomes
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Monocyte Dnases signal, circulating free DNA and DNase1 and DNase1L3 activities will be measured in each group by dosage
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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.
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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.
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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.
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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.
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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.
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Correlation between levels of platelet activation markers studied (CD154, beta thromboglobulin, platelet factor 4, platelet microparticles, soluble CD62, RANTES, GRO-alpha and HMGB-1).
More Details
| NCT Number: | NCT04080453 |
|---|---|
| Other IDs: | CHUBX 2017/20 |
| Study URL: | https://clinicaltrials.gov/study/NCT04080453 |
Last updated: Sep 29, 2023