Association Between Muscle L3 CT Scan Muscle Derived Parameters of Muscle Function Upon Intensive Care Unit Admission and 3 Months Mortality After ICU Discharge for Patients Admitted for Septic Shock. The SIMS Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 196
- 试验地点
- 4
- 主要终点
- vital status
研究概览
简要总结
Muscle dysfunction in intensive care units is associated with significant morbidity and mortality. During septic shock, there is an increased catabolism and systemic inflammation resulting in quantitative and qualitative muscle impairment. In the intensive care setting, quantitative and qualitative assessment of muscle function is challenging due to critical care environments (general anesthesia, altered consciousness, etc.). CT scan measurement at the 3rd lumbar level has been proposed to evaluate muscle function. Recent retrospective studies have highlighted increased mortality among patients with muscle mass impairment and/or decreased muscle density.
详细描述
To date, no prospective study has assessed the prognostic value of CT scan measurements of muscle function upon admission to intensive care units for patients treated for septic shock. That is the aim of this project.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patients hospitalized in intensive care for septic shock defined by the presence of a documented or suspected infection, plasma lactate >2 mmol/L, and an increase in SOFA score of more than 2 points from baseline (Singer et al., 2016)
- •Patients who underwent a non-contrast CT scan within 48 hours prior to admission and up to 24 hours after admission to intensive care
- •Patients affiliated with or eligible for social security
排除标准
- •Patients with a neuromuscular disease prior to admission to intensive care.
- •Pregnant women
- •Patients under guardianship and/or conservatorship
- •Refusal of consent.
结局指标
主要结局
vital status
时间窗: 90 days
alive or dead
Total muscle mass measured at L3 (cm²/m² )
时间窗: at inclusion
Total muscle mass measured at L3 by CT scan, normalized by patient height (Skeletal Muscle Index), in cm²/m² upon admission to the ICU (Correlation between three L3 CT scan parameters of muscle function upon admission to the intensive care unit and the risk of mortality at 3 months after ICU discharge in septic shock patients).
Total muscle density measured at L3 ( Hounsfield Unit)
时间窗: at inclusion
\- Total muscle density measured at L3 by CT scan (Skeletal Muscle Density) in HU upon admission to the ICU (Correlation between three L3 CT scan parameters of muscle function upon admission to the intensive care unit and the risk of mortality at 3 months after ICU discharge in septic shock patients).
Total fat excretion fraction measured at L3 (%)
时间窗: at inclusion
Total fat excretion fraction measured at L3 (Fat Fraction) by CT scan upon admission to the ICU (Correlation between three L3 CT scan parameters of muscle function upon admission to the intensive care unit and the risk of mortality at 3 months after ICU discharge in septic shock patients).
次要结局
- SOFA (Sequential Organ Failure Assessment) severity score(at inclusion, 10 days.)
- Kinetics of changes in muscle assessment(Day 1, 10, 90)
- Total fat excretion fraction measured at L3 (%)(at inclusion, 10 days, 90 days)
- Total muscle density measured at L3 ( Hounsfield Unit)(at inclusion, 10 days, 90 days)
- Total muscle mass measured at L3 (cm²/m² )(at inclusion, 10 days, 90 days)
- MRC score (Medical Research Council)(at discharge from intensive care, 90 days)
- Handgrip test (Kg)(at discharge from intensive care, 90 days)