Septic Shock
Conditions
Keywords
coagulation, highlighting of biomarkers
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
University Hospital, Rouen
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any adult patient admitted to critical care for sepsis defined by a SOFA score \> or = 2 or an increase of at least 2 points if there was organ dysfunction pre-existing to the infection. * For the inflammatory control group, we will include adult patients who have required extracorporeal circulation for more than 1 hour for cardiac surgery. * Patients who have read and understood the information letter and do not object to participating in the study * Patients affiliated with a social security scheme *
Exclusion criteria
* Patient refusal * Pregnant, parturient, or breastfeeding woman * Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection/guardianship or curatorship * Person who does not understand or speak French * Moribund * Febrile aplasia * Hematological diseases * Decompensated cirrhosis * Ongoing chemotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Days 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the impact of the immature platelet fraction on the occurrence of thrombocytopenia | days 28 | Occurrence of thrombocytopenia defined by a fall \> or = to 30% of its baseline value or a platelet count \< less than 150,000 G/L |
| Assess the impact of the immature platelet fraction on the progression to disseminated vascular coagulopathy | Days 28 | Demonstration of disseminated intravascular coagulation (DIC) |
| Evaluation of the impact of the immature platelet fraction on the occurrence of thromboembolic events | Days 28 | Evidence of the onset of thromboembolic venous disease |
| Assessment of the occurrence of multiple organ failure syndrome | Days 28 | Evidence of a multi-organ failure syndrome defined by the occurrence of at least 2 organ failures |
| Assessment of the occurrence of recourse to mechanical ventilation | Days 28 | Highlighting the use of mechanical ventilation |
| Assessment of mortality in intensive care, in hospital and on D28 | At enrollment visit, day 1, days 3, days 7 and Days 28 | Determination of Mortality in intensive care, in hospital and on D28 |
Countries
France
Contacts
STUDY_DIRECTORPerrine PL LEPRETRE, Doctor
University Rouen Hospital
Outcome results
None listed