Predictive Mini-bolus Fluid Responsiveness in Pediatric Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Cardiac output variability (ΔCO)
研究概览
简要总结
Severe sepsis and septic shock remain of particular gravity in children with a current mortality of about 20 % , despite the international prevention campaigns " survival sepsis campaign ". Septic shock associates a macrocirculatory and a microcirculatory dysfunction. The volume expansion remains the treatment of severe sepsis at the initial phase supplemented by the use of vasopressors and / or inotropes. Nevertheless , it is essential to predict the fluid responsiveness after volemic expansion because fluid overload is associated with an increased morbidity in children. In studies , the volume expansion is considered effective if it allows an increase in cardiac output of more than 15 % compared to the basal level. However, their conditions of use remain very restrictive and not applicable to most of our patients ( tidal volume ≥ 7ml / kg , PEEP sufficient , absence of cardiac arrhythmia and effective sedation ) . To date , no index can be used for all patients with invasive mechanical ventilation.
It therefore seems appropriate to develop new tests to predict the response to volume expansion in children with septic shock hospitalized in pediatric intensive care.
A recent study has validated a test to predict the response to volume expansion in adults: injection of a mini-bolus of 50 ml of saline over 10s.
The aim of the study is to evaluate the effect of mini bolus fluid to predict response to fluid expansion in pediatric septic shock.
详细描述
Severe sepsis and septic shock remain of particular gravity in children with a current mortality of about 20 % , despite the international prevention campaigns " survival sepsis campaign " . Septic shock associates a macrocirculatory and a microcirculatory dysfunction. The volume expansion remains the treatment of severe sepsis at the initial phase supplemented by the use of vasopressors and / or inotropes . Nevertheless , it is essential to predict the fluid responsiveness after volemic expansion because fluid overload is associated with an increased morbidity in children . In studies , the volume expansion is considered effective if it allows an increase in cardiac output of more than 15 % compared to the basal level . However , their conditions of use remain very restrictive and not applicable to most of our patients ( tidal volume > 7ml / kg , PEEP sufficient, absence of cardiac arrhythmia and effective sedation ) . To date , no index can be used for all patients with invasive mechanical ventilation .
It therefore seems appropriate to develop new tests to predict the response to volume expansion in children with septic shock hospitalized in pediatric intensive care.
A recent study has validated a test to predict the response to volume expansion in adults : injection of a mini-bolus of 50 ml of saline over 10s.
The aim of the study is to evaluate the effect of mini bolus fluid to predict response to fluid expansion in pediatric septic shock.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 28 Days 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Baby (>28 days) or children < 15 years
- •Hospitalisation in paediatric intensive
- •Clinico-biological table compatible with severe sepsis or septic shock (likely or documented)
- •Requiring the use of invasive mechanical ventilation
- •Affiliate or beneficiary of a social security
- •Legal guardians Consent Form or Emergency Procedure
排除标准
- •Any serious hemodynamic clinical situation that would be delayed by inclusion in the protocol
- •Patient with shunt heart disease
- •Patient in spontaneous or non-invasive ventilation or CPAP
- •Patient with a contraindication to volemic/fluid expansion (major cardiac dysfunction, acute renal failure)
- •Patient with cardiac arrest upper 5 min
- •Postcardiotomia
结局指标
主要结局
Cardiac output variability (ΔCO)
时间窗: 15 minutes
Cardiac output : ΔCO (mL/min) = VES (ml)\* heart rate and VES (cm3)= ITVA0(cm) \* SA0 (cm2)
次要结局
- Heart rate variation (ΔHR)(15 minutes)
- Microvascular Flow Index variation (ΔMFI)(15 min)
- Pulse pressure variation (ΔPP)(15 minutes)
- Velocity time-index variation (ΔVTI)(15 minutes)
- Systolic ejection volume variation (ΔSEV)(15 minutes)
- Systolic, diastolic and mean arterial pressure variation (ΔSAP, ΔDAP, ΔMAP)(15 minutes)
- Proportion Perfused Vessels variation (ΔPPV)(5 minutes)