The Influence of In-line Microfilters on Systemic Inflammation in Adult Critically Ill Patients: A Prospective, Randomized, Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 504
- 试验地点
- 2
- 主要终点
- Number of days in the intensive care unit with the systemic inflammatory response syndrome
研究概览
简要总结
Studies showed that infusion or injection of drugs and fluids results in introduction of microparticles into the bloodstream. These microparticles may cause organ damage and stimulate the immune system thus aggravating the underlying disease. Given that critically ill patients are characteristically suffering from a high disease severity and receive large amounts of fluids and drugs, they may be at particular risk of harm by these microparticles. In-line microfilters have been shown to clear microparticles from intravenous drugs and solutions. The investigators hypothesize that use of in-line microfilters reduce the days with the systemic inflammatory response syndrome in adult critically ill patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •critical illness
- •expected length of stay in the intensive care unit > 24 hours
- •central venous catheter in place or placed within the first 24 hours
排除标准
- •age < 18 years
- •pregnancy
- •neutropenia or known immunesuppresion
- •limited intensive care
- •inclusion into another clinical trial
- •refusal of written informed consent
研究组 & 干预措施
Use of in-line microfilters
干预措施: In-line microfilter (Supor IV Filter; Pall Corporation, Port Washington, New York) (Device)
Standard therapy without the use of in-line microfilters
结局指标
主要结局
Number of days in the intensive care unit with the systemic inflammatory response syndrome
时间窗: participants will be followed for the duration of ICU stay, an expected average of 5 days
次要结局
- Duration of mechanical ventilation(participants will be followed for the duration of ICU stay, an expected average of 5 days)
- Incidence of acute lung injury and the acute respiratory distress syndrome(participants will be followed for the duration of ICU stay, an expected average of 5 days)
- Average number of days with the systemic inflammatory response syndrome during the intensive care unit stay(participants will be followed for the duration of ICU stay, an expected average of 5 days)
- Cumulative insulin requirements during the intensive care unit stay(participants will be followed for the duration of ICU stay, an expected average of 5 days)
- Number of days with hypo- or hyperglycemic blood sugar levels(participants will be followed for the duration of ICU stay, an expected average of 5 days)
- Incidence of the systemic inflammatory response syndrome during the intensive care unit stay(participants will be followed for the duration of ICU stay, an expected average of 5 days)
- Incidence of nosocomial candida infections during the intensive care unit stay(participants will be followed for the duration of ICU stay, an expected average of 5 days)
- Length of stay in the intensive care unit(participants will be followed for the duration of ICU stay, an expected average of 5 days)
- Maximum C-reactive protein serum concentrations during the intensive care unit stay(participants will be followed for the duration of ICU stay, an expected average of 5 days)
- Maximum leukocyte count during the intensive care unit stay(participants will be followed for the duration of ICU stay, an expected average of 5 days)
- Incidence of nosocomial infections during the intensive care unit stay(participants will be followed for the duration of ICU stay, an expected average of 5 days)
- Incidence of venous thrombosis during the intensive care unit stay(participants will be followed for the duration of ICU stay, an expected average of 5 days)
研究者
Martin W Duenser, MD, DESA, EDIC
Dr.
University of Salzburg