Early Intervention With Exercise in Critically Ill Patients With Sepsis: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Fat free mass ie muscle mass (lean tissue)
研究概览
简要总结
This study will investigate whether early exercise in critically ill patients will decrease inflammatory markers, increase pro-inflammatory markers and prevent loss of muscle mass.
详细描述
This study will investigate the effects of an early targeted rehabilitation program on inflammatory markers and muscle mass in patients with sepsis syndromes in intensive care.
The Primary Hypothesis is that an early targeted rehabilitation ICU patients with sepsis syndromes over 7 days will Prevent loss of lean muscle mass by within 7 days of recruitment to the study. Decrease pro-inflammatory and increase anti-inflammatory cytokines within 7 days of recruitment to the study.
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 (Outcomes Assessor)
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
- •Systemic inflammatory response syndrome with a proven or suspected infectious etiology.
- •18 years and over
- •Relatives willing to give consent
- •Admitted to intensive care and likely to remain ventilated for > 48 hours
排除标准
- •Patients with septic shock unresponsive to maximal treatment or who are moribund or have an expected mortality within 48 hours
- •Head injuries
- •Burn injury
- •Multiple lower limb fractures
结局指标
主要结局
Fat free mass ie muscle mass (lean tissue)
时间窗: Change from baseline to one week, then change from baseline to two weeks
Fat free mass will be measured by Multi-Frequency Bioelectrical Impedance Spectroscopy (BIS) (ImpediMed SFB7, ImpediMed Ltd, Brisbane, Australia).
次要结局
- Interleukin 6(Change from baseline to measurements taken daily for 7 days)
- Tumour necrosis factor alpha (TNF-alpha)(Change from baseline to measurements taken daily for 7 days)
- Interleukin 10(Change from baseline to measurements taken daily for 7 days)
- Vital signs - observation only(Fifteen minutes pre and post every exercise session recorded every 10 seconds)