Evaluation of the Prognostic Value of Immature Platelet Fraction in Septic Patients Admitted to Critical Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Febrile aplasia
- •Hematological diseases
- •Decompensated cirrhosis
- •Ongoing chemotherapy
研究组 & 干预措施
Sepsis Group
Patient admitted for sepsis in critical care
Inflammatory control group
Patient admitted for an anesthesia consultation for cardiac surgery under extracorporeal circulation
结局指标
主要结局
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.
时间窗: 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
次要结局
- Evaluation of the impact of the immature platelet fraction on the occurrence of thromboembolic events(Days 28)
- Assessment of the occurrence of multiple organ failure syndrome(Days 28)
- To assess the impact of the immature platelet fraction on the occurrence of thrombocytopenia(days 28)
- Assess the impact of the immature platelet fraction on the progression to disseminated vascular coagulopathy(Days 28)
- Assessment of the occurrence of recourse to mechanical ventilation(Days 28)
- Assessment of mortality in intensive care, in hospital and on D28(At enrollment visit, day 1, days 3, days 7 and Days 28)