Hypothermia Risk With Continuous Renal Replacement Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Temperature, accuracy
研究概览
简要总结
The present study aims at testing if the TherMax blood warmer is more accurate and reliable in reaching and maintaining chosen target temperature during continuous renal replacement therapy as compared to the Prismaflo IIS blood warmer used for the PrismaFlex system.
详细描述
Blood warming devices during continuous renal replacement therapy (CRRT) have not been adequately tested.
The novel TherMax blood warmer for the newly introduced PrisMax System heats blood and replacement solutions via a dry heat plate system. In contrast, the PRISMAFLO IIS Blood Warmer for PRISMAFLEX System uses an electric heating sleeve on a standard CRRT filter set.
Data on adverse events (AE) during continuous renal replacement therapy (CRRT) has been studied and one of the most common AE was hypothermia, reported in 44% of all cases.
The present study aims at testing if the TherMax blood warmer is more accurate and reliable in reaching and maintaining chosen target temperature during CRRT as compared to the blood warmer used for the PrismaFlex system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (18-100 years) critically ill patients treated with CRRT.
排除标准
- •Patients under 18 years of age. Non-RRT patients.
结局指标
主要结局
Temperature, accuracy
时间窗: 24 hours
During use of Thermax; hourly difference between prescribed temperature-measured temperature; accuracy 0,1 Celsius
次要结局
- Temperature, differences(12-18 hours (six hour warming period))
- Historic comparator(24 hours)
研究者
Max Bell
MD, PhD, Principal Investigator
Karolinska University Hospital