An Outcomes Comparison of ACCM/PALS Guidelines For Pediatric Septic Shock With and Without Central Venous Oxygen Saturation Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 268
- 试验地点
- 4
- 主要终点
- 28-day mortality
研究概览
简要总结
The purpose of this study was to compare ACCM/PALS guidelines performed with and without central venous oxygen saturation monitoring on the morbidity and mortality rate of children with severe sepsis and septic shock.
详细描述
Background: ACCM/PALS guidelines addresses early correction of pediatric septic shock using physical examination supplemented by indirect measures of cardiac output such as central venous or superior vena cava oxygen saturation (ScvO2>70%) in a goal directed approach. However, these endpoints are based on unsupported evidence. The purpose of this study was to compare ACCM/PALS guidelines performed with and without ScvO2 on the morbidity and mortality rate of children with severe sepsis and septic shock.
Methods: Children and adolescents with severe sepsis or fluid-refractory septic shock were recruited at two university-affiliated hospitals and randomly assigned to ACCM/PALS without, or with an ScvO2 goal directed (goal ScvO2 > 70%) resuscitation. Twenty-eight day mortality is the primary end point.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with severe sepsis or fluid-refractory septic shock that had not responded after 40 mL/kg of any resuscitation fluid or that required cardiovascular agents at any time during resuscitation
排除标准
- •refusal to sign the written informed consent
- •age less than 1 month or older than 19 years
- •uncorrected cyanotic heart disease
- •patients receiving exclusive palliative care
- •patients that arrived from other hospitals more than 6 hours after the diagnosis of severe sepsis or septic shock.
结局指标
主要结局
28-day mortality
次要结局
- Number of organ dysfunction
- Administered treatments
- Duration of cardiovascular agents therapy
- Duration of mechanical ventilation
- Length of Pediatric Intensive Care Unit stay
- Days free of cardiovascular agents
- Days free of mechanical ventilation