Mortality and Muscle Mass Loss in Critically Ill Patients: A Prospective, Observational, Multicenter Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 386
- 试验地点
- 1
- 主要终点
- Relationship between muscle loss and 28 day mortality
研究概览
简要总结
The aim of the study is to monitor changes in muscle mass in critically ill patients and to verify whether a decrease in muscle mass of ≥10% during the first 7 days of hospitalization is associated with increased 28-day mortality. We will be used ultrasoud for measurement the rectus femoris cross sectional area.
详细描述
All patients will be admitted to participating ICU centers from December 2025 to December 2026 will be screened and enrolled based on the inclusion and exclusion criteria. Informed consent will be requested. Ultrasound measurements will be performed by the same investigator within the first 24h after ICU admssion and again on day 7 of the patient´s ICU stay. All patient data will be entered into case report form by a study physician. In the follow-up will be determined 28 mortality.
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
- •Conditions affecting the nervous system with involvement of the thigh muscle
- •Inability to cooperate during ultrasound examination
- •Inability to perform ultrasound examination on day 7
- •9. Inability to perform ultrasound examination on day 7
结局指标
主要结局
Relationship between muscle loss and 28 day mortality
时间窗: 28 days after enrollment
Critically ill patients with a ≥10% decrease in rectus femoris cross-sectional area have increased 28 day mortality.
次要结局
- Incidence of a significant decrease in rectus femoris cross-sectional area(first 7 days of ICU stay)
- Incidence of an insignificant decrease in rectus femoris cross-sectional area(first 7 days ICU stay)
研究者
Roman Gal
head of the department
Brno University Hospital