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| ID | Type | Description | Link |
|---|---|---|---|
| N° IDRCB : 2022-A02612-41 | Other Identifier | ANSM |
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Sepsis is a public health issue responsible for six million deaths worldwide each year. It is one of the leading causes of admission and morbidity and mortality in critical care. Its most severe form, septic shock, is responsible for a picture of multiple organ failure syndrome with a high mortality rate estimated at 38%. It appears important to identify routinely available and low-cost biomarkers to identify patients at risk of adverse outcomes.
In the pathophysiology of host defense against infection, coagulation plays a major role. In the most severe forms of sepsis, there is an activation of coagulation, particularly platelets, which can cause an alteration of microcirculation and contribute to organ failure. This mechanism is called thromboinflammation. The appearance of thrombocytopenia in sepsis is a risk factor for severity and intrahospital mortality. Immature (or reticulated) platelets are young platelets that have just been released by the bone marrow. They are more prothrombotic and hyperactive than more mature platelets. They are a good marker of thrombopoiesis and platelet renewal, and can be easily obtained routinely on a complete blood count. Several studies show that the immature platelet count and/or fraction (IPF) could be a useful tool for predicting the development of sepsis and its severity. It appears interesting to study these IPFs in patients with sepsis to identify them and implement more aggressive therapies to prevent adverse outcomes in these patients. To distinguish between sepsis and inflammation and validate this marker, it will be compared to an inflammatory group using patients who underwent cardiopulmonary bypass as part of cardiac surgery.
The main objective of this study is to investigate the potential impact of the immature platelet fraction on the prognosis at day 28 of patients admitted to critical care for sepsis or septic shock.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sepsis Group | Patient admitted for sepsis in critical care | ||
| Inflammatory control group | Patient admitted for an anesthesia consultation for cardiac surgery under extracorporeal circulation |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the impact of the immature platelet fraction of patients admitted to intensive care for sepsis or septic shock on their prognosis at day 28. | Measurement of the fraction of immature platelets at admission in patients with sepsis or septic shock defined by the composite criterion calculated on the occurrence of death at 28 days of follow-up | Days 28 |
| Evaluation of the impact of the immature platelet fraction of patients admitted to intensive care for sepsis or septic shock on their prognosis at day 28. | Measurement of the fraction of immature platelets at admission in patients with sepsis or septic shock defined by the composite criterion calculated on the occurrence of organ failure: implementation of extrarenal purification and/or renal failure KDIGO 3 and/or moderate to severe acute respiratory distress syndrome and/or intense vasoplegic septic shock with noradrenaline > 0.25 µg/kg/min or vasopressin > 0.02 IU/h and/or myocardial dysfunction with venous oxygen saturation < 60 or a cardiac index < 2.2 l/min/m2 and/or occurrence of disseminated intravascular coagulation (DIC) | Days 28 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the impact of the immature platelet fraction on the occurrence of thrombocytopenia | Occurrence of thrombocytopenia defined by a fall > or = to 30% of its baseline value or a platelet count < less than 150,000 G/L | days 28 |
| Assess the impact of the immature platelet fraction on the progression to disseminated vascular coagulopathy |
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Inclusion Criteria:
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Patients admitted to critical care for sepsis or septic shock
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| Name | Affiliation | Role |
|---|---|---|
| Perrine PL LEPRETRE, Doctor | University Rouen Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Rouen Hospital | Rouen | 76031 | France |
The data provided will be the property of the sponsor and will be used solely for its own research activities.
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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At each patient follow-up time (At enrollment visit, 1-day visit, 3-day visit, 7-day visit), 4 tubes of 4 mL of blood will be collected (a total of 16 mL): 2 EDTA tubes for research, 1 citrated tube and one dry tube.
Demonstration of disseminated intravascular coagulation (DIC) |
| Days 28 |
| Evaluation of the impact of the immature platelet fraction on the occurrence of thromboembolic events | Evidence of the onset of thromboembolic venous disease | Days 28 |
| Assessment of the occurrence of multiple organ failure syndrome | Evidence of a multi-organ failure syndrome defined by the occurrence of at least 2 organ failures | Days 28 |
| Assessment of the occurrence of recourse to mechanical ventilation | Highlighting the use of mechanical ventilation | Days 28 |
| Assessment of mortality in intensive care, in hospital and on D28 | Determination of Mortality in intensive care, in hospital and on D28 | At enrollment visit, day 1, days 3, days 7 and Days 28 |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |