Impact of Cytosorb and CKRT on Hemodynamics in Pediatric Patients With Septic Shock: the PedCyto Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Vasopressors and inotropes reduction
研究概览
简要总结
Impact of the hemoadsorption with Cytosorb on hemodynamic in pediatric patients with septic shock: a prospectic pediatric pilot study
详细描述
Prospective interventional pilot study included children with septic shock, weight ≥ 10 Kgs and requiring continuous kidney replacement therapy. Cytosorb (CytoSorbents Inc, New Jersey, USA) cartridge was added to CKRT every 24 hours for a maximum of 96 hours. A control group of matched patients was also identified from an external database. The primary outcome of the study was the proportion of patients who achieved an equal or more than 50% relative reduction in vasopressors or inotropes dose from baseline to the end of treatment. Secondary outcomes included doses of vasopressors and inotropes, hemodynamic and biological changes, changes in severity scores and 28-day mortality.
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
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children weighing ≥ 10 kg
- •Septic shock as defined by the International Pediatric Consensus Conference
- •Need for Continuous Renal Replacement Therapy (CRRT) = acute kidney injury defined by the KDIGO criteria (16) AND/OR fluid overload ≥ 10%
排除标准
- •Refused consensus by parents
- •Concomitant use of other extracorporeal blood purification techniques.
结局指标
主要结局
Vasopressors and inotropes reduction
时间窗: 96 hours
Proportion of patients who achieved a significant reduction in vasopressors or inotropes dose from baseline to the end of treatment.
次要结局
- Changes in hemodynamic parameters(96 hours)
研究者
Gabriella Bottari
Medical Doctor, Principal Investigator, Pediatric Intensivist
Ospedale Pediatrico Bambin Gesù