NCT07191054撤回不适用
Prospective Trial Of Patient Outcomes and PALS Sepsis Guideline Adherence In Patients Fluid Resuscitated With The LifeFlow® Rapid Infuser Compared To Traditional Methods
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Time to third bolus completion
研究概览
简要总结
This is a prospective, comparative, blinded, randomized study to prove the safety, efficacy and ease of use of the LifeFlow® device in pediatric patients presenting to an emergency department with concern for sepsis. This study will include 600 patients, 300 will receive the LifeFlow® device to deliver intravenous fluids while another 300 patients will receive the conventional push/pull method.
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
- Single (Investigator)
入排标准
- 年龄范围
- 1 Year 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Less than 19 years old
- •Trigger the Best Practice Alert in triage
- •Treating physician elects to do the full sepsis bundle.
排除标准
- •Less than 20kg in weight
- •Patients on diuretics for cardiac or renal conditions
- •Patients who cannot communicate in either English or Spanish
结局指标
主要结局
Time to third bolus completion
时间窗: 60 Minutes
Time To first bolus completion
时间窗: 20 Minutes
Time to hospital admission
时间窗: 24 hours
Time from presentation to the ER until admission to the hospital
Nursing satisfaction
时间窗: 1 day
Likert scale of satisfaction with style of fluid administration used. From not satisfied to extremely satisfied.
次要结局
- Hospital Length of Stay(Days)
- ICU days(Days)
- Vasoactive medication use(1 day)
- Morbidity and Mortality(1 day)
研究者
研究点 (2)
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