NCT02903082终止不适用
Following of Myeloid-derived Suppressor Cells (MDSC) in Severe Sepsis: What Relationship With Systemic Inflammatory Syndrome?
University Hospital, Limoges1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2015年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Change in Peripheral Blood MDSC concentration during ICU hospitalization for Severe Sepsis
研究概览
简要总结
Sepsis remains a major cause of death in developed countries. A better understanding of the mechanisms involved in the regulation of inflammatory and immune response of patients with severe sepsis is an important step that could open the way for new therapeutic approaches.
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
- •Patient ≥18 years old
- •Patient with two criteria of systemic inflammatory response syndrome and one of the four following criteria within 24 hours of hospitalization in ICU:
- •Lactate >4 mmol/L
- •PaO2 / FiO2 <200 in the presence of lung disease as infectious source
- •Vasopressor: adrenaline or noradrenaline ≥0.25 µg/kg/min for at least 6 hours to maintain a systolic blood pressure ≥90 mmHg or mean arterial pressure ≥65 mmHg
- •Thrombocytopenia linked to sepsis with platelet count <100,000 / ml or a decrease ≤50% within 48 hours
排除标准
- •Pregnancy
- •progressive solid cancer
- •HIV infection
- •History of blood or inflammatory disease
- •long-term immunosuppressive treatment
- •Prior episode of Sepsis in the previous month
- •Chronic Dialysis Patient
- •Patient under guardianship
- •Patient not affiliated with a social security system
结局指标
主要结局
Change in Peripheral Blood MDSC concentration during ICU hospitalization for Severe Sepsis
时间窗: Average 30 days - Patients will be followed up until hospital discharge
Number of patients showing an increase of Myeloid derived suppressive cells from baseline at Day 30. Kinetic of Myeloid derived suppressive cells through weekly measures of Absolute Cell Counts (using flow cytometry)
次要结局
- Incidence of hospital acquired secondary infections at Day 28(Day 28)
- Assessment of MDSC functional status(Day 0 vs Days 3, 7, 14, 21, 28)
- Immuno- inflammatory status(Day 0, Day3, Day 7 and once a week until the intensive care unit discharge)
- MDSCs presence in the blood and bone marrow.(Day 0)
- Assessment of MDSC specific gene expressions(Day 0 vs Days 3, 7, 14, 21, 28)
- Mortality(Day 28 and Day 90)
- SOFA score(Day 0, Day3, Day 7 and once a week until the intensive care unit discharge)
研究者
研究点 (1)
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