Characterisation of the Inflammatory, Metabolic, and Mitochondrial Profiles in the Context of Post-Intensive Care Muscle Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Quadriceps strength
研究概览
简要总结
More and more patients survive a critical illness requiring admission to the intensive care unit, but they may be left with sequelae that are independent of the initial pathology. From a physical standpoint, the most visible complication is intensive care unit-acquired muscle weakness. A major factor in the development and persistence of muscle dysfunction appears to be the inflammatory response and the neuroendocrine stress response triggered by the initial critical insult. Persistence of inflammation beyond ICU discharge has been demonstrated in several studies. In response to inflammation, there is also increased oxidative stress associated with mitochondrial dysfunction.
The objectives of the present study are therefore:
to determine whether the broad inflammatory and metabolic profile of patients who have survived an ICU stay can predict the trajectory of muscle performance over the three months following ICU discharge; to compare this profile and muscle performance with those of non-critically ill surgical patients who have undergone a standardized inflammatory stress of lower intensity than that associated with critical illness; to investigate mitochondrial function in skeletal striated muscle after ICU stay, in light of the inflammatory and metabolic profile; to assess whether abnormalities in mitochondrial function also affect tissues other than skeletal muscle, in particular circulating blood mononuclear cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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:
- •anticipated ICU stay >= 7 days
- •Major abdominal surgery
- •elective surgery
排除标准
- •Active malignancy
- •Inherited metabolic disorder
- •Known muscle disease
- •Pregnancy
- •Patient refusal
- •Patient unable to express informed consent (dementia, confusion)
- •Known coagulation disorder (cirrhosis, genetic coagulopathy) or thrombocytopenia < 100,000/mm³ on the day of biopsy, anemia with hemoglobin < 9 g/dL on the day of biopsy, or treatment with anticoagulant agents (contraindication to muscle biopsies only)
- •Pacemaker or other implanted electronic device (contraindication to bioelectrical impedance analysis only)
- •Oxygen therapy (contraindication to indirect calorimetry during spontaneous ventilation)
研究组 & 干预措施
ICU patients
Lab and clinical investigations to characterize the metabolic and muscle profile
干预措施: Inflammation markers (Diagnostic Test)
ICU patients
Lab and clinical investigations to characterize the metabolic and muscle profile
干预措施: Blood nucleosomes (Diagnostic Test)
ICU patients
Lab and clinical investigations to characterize the metabolic and muscle profile
干预措施: Erythrocyte membrane fatty acid content (Diagnostic Test)
ICU patients
Lab and clinical investigations to characterize the metabolic and muscle profile
干预措施: measurement of myokines (Diagnostic Test)
ICU patients
Lab and clinical investigations to characterize the metabolic and muscle profile
干预措施: Resting energy expendure (Diagnostic Test)
ICU patients
Lab and clinical investigations to characterize the metabolic and muscle profile
干预措施: body composition (Diagnostic Test)
ICU patients
Lab and clinical investigations to characterize the metabolic and muscle profile
干预措施: Omics (Diagnostic Test)
ICU patients
Lab and clinical investigations to characterize the metabolic and muscle profile
干预措施: Monocyte profile (Diagnostic Test)
Surgical patients
Lab and clinical investigations to characterize the metabolic and muscle profile
干预措施: Inflammation markers (Diagnostic Test)
Surgical patients
Lab and clinical investigations to characterize the metabolic and muscle profile
干预措施: Blood nucleosomes (Diagnostic Test)
Surgical patients
Lab and clinical investigations to characterize the metabolic and muscle profile
干预措施: Erythrocyte membrane fatty acid content (Diagnostic Test)
Surgical patients
Lab and clinical investigations to characterize the metabolic and muscle profile
干预措施: measurement of myokines (Diagnostic Test)
Surgical patients
Lab and clinical investigations to characterize the metabolic and muscle profile
干预措施: Resting energy expendure (Diagnostic Test)
Surgical patients
Lab and clinical investigations to characterize the metabolic and muscle profile
干预措施: body composition (Diagnostic Test)
Surgical patients
Lab and clinical investigations to characterize the metabolic and muscle profile
干预措施: Omics (Diagnostic Test)
Surgical patients
Lab and clinical investigations to characterize the metabolic and muscle profile
干预措施: Monocyte profile (Diagnostic Test)
结局指标
主要结局
Quadriceps strength
时间窗: between 1 and 7 days after ICU discharge and 3 months after ICU discharge in the critically ill patients, or the day after the surgery and 3 months after the surgery in surgical patients
Quadriceps strength in Newton, measured using a handheld dynamometer (MicroFet)
Handgrip strength
时间窗: between 1 and 7 days after ICU discharge and 3 months after ICU discharge in the critically ill patients, or the day after the surgery and 3 months after the surgery in surgical patients
Hangrip strength in kg, measured young an handheld dynamometer (Jamar)
Muscle mitochondrial function
时间窗: between 1 and 7 days after ICU discharge and 3 months after ICU discharge in the critically ill patients, or perioperatively and 3 months after the surgery in surgical patients
Oxygraphy performed on a muscle sample
Muscle function
时间窗: between 1 and 7 days after ICU discharge and 3 months after ICU discharge in the critically ill patients, or perioperatively and 3 months after the surgery in surgical patients
Transcriptomic analysis in muscle sample (muscle biopsy)
Physical function
时间窗: between 1 and 7 days after ICU discharge and 3 months after ICU discharge (or the day after surgery and 3 months after hospital discharge)
2-minute walking test
Muscle mass
时间窗: between 1 and 7 days after ICU discharge and 3 months after ICU discharge in the critically ill patients, or the day after the surgery and 3 months after the surgery in surgical patients
Quadriceps muscle thickness assessed by ultrasound
次要结局
未报告次要终点
研究者
Anne-Françoise Rousseau
Associate Professor
University of Liege
