Muscle Mass Loss in Critically Ill and Its Risk Factors. A Prospective Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Muscle mass loss
研究概览
简要总结
The purpose of the study is to describe the change in muscle mass in critically ill patients. The study will examine rectus femoris cross sectional area with ultrasound and identify risk factors of this changes.
详细描述
The study will commence following the Approval by The Ethics Research Committee. All patients admitted to our ICU from the 1st of March 2019 to the 31st of August 2019 will be enrolled after fulfilling the inclusion criteria and in the absence of any exclusion criteria. Informed consent will be requested. Ultrasound measurement of rectus femoris cross sectional area will be performed in first 24 hours after admission to ICU.
Study data will be entered in study form. The ultrasound measurement will be repeated on day 7 of hospitalisation.
Changes in rectus femoris cross sectional area and potential risk factors will be analysed. The length of ICU length of stay and 28-day mortality will be also monitored.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •age ≥18 years
- •mechanical ventilation expected for at least 48 hours
排除标准
- •Clinical Frailty Score above 7 prior admission
- •neuromuscular disease in previous medical history
- •amputated lower extremities
- •trauma of lower extremities involving tights
- •age under 18 years
- •inability to perform ultrasound examination
- •death or discharge prior completion of protocol
- •full verticalization prior completion of protocol
结局指标
主要结局
Muscle mass loss
时间窗: 7 days
Change in cross sectional area of rectus femoris muscle estimated by ultrasound
次要结局
- 28 day mortality(28 days after enrolment)