Septic cArdiac Deficiency and MenIngococcal seveRe Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Repeated brain natriuretic peptide (BNP) blood level
研究概览
简要总结
Use of brain natriuretic peptide to evaluate the cardiac function in the course of meningococcal septic shock or severe sepsis.
详细描述
OBJECTIVES: determining sensibility and specificity of BNP blood level to detect myocardial dysfunction in septic shock or severe sepsis due to Neisseria meningitidis in children.
METHODS: Prospective multicentric clinical trial including 7 French pediatric intensive care units. Serial cardiac ultra sounds and blood sampling will be done for patients hospitalized for purpura fulminans beginning at the time of admission in pediatric intensive care. Any child from 6 months to 18 years without preexisting cardiac disease and presenting with purpura fulminans will be enrolled after obtaining consent of both parents. From adult's studies on septic shock and BNP, a total number of 30 patients was calculated to be necessary to prove the interest of BNP in this indication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6 months to 18 years aged
- •without previous cardiac pathology
- •hospitalized in the participating pediatric intensive care units for serious sepsis with extensive purpura
排除标准
- •Heart malformative disorder with right-left shunt
- •Pre-existent known cardiac insufficiency whatever is the origin
- •Concomitant participation in another trial
- •Patient in period of exclusion from another trial
- •Not membership in a national insurance scheme
结局指标
主要结局
Repeated brain natriuretic peptide (BNP) blood level
时间窗: Up to day 5
次要结局
- PRISM II gravity score(Up to day 5)
- Repeated cardiac echography(Up to day 5)
- Organ failure PELOD score(Up to day 5)
- mortality and morbidity (aftereffects)(Day 28 and hospital discharge)
- Troponin rate(Up to day 5)