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临床试验/NCT07329530
NCT07329530招募中不适用

Characterisation of the Inflammatory, Metabolic, and Mitochondrial Profiles in the Context of Post-Intensive Care Muscle Dysfunction

Anne-Françoise Rousseau1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年12月1日最近更新:
干预措施

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

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

Experimental

Lab and clinical investigations to characterize the metabolic and muscle profile

干预措施: Inflammation markers (Diagnostic Test)

ICU patients

Experimental

Lab and clinical investigations to characterize the metabolic and muscle profile

干预措施: Blood nucleosomes (Diagnostic Test)

ICU patients

Experimental

Lab and clinical investigations to characterize the metabolic and muscle profile

干预措施: Erythrocyte membrane fatty acid content (Diagnostic Test)

ICU patients

Experimental

Lab and clinical investigations to characterize the metabolic and muscle profile

干预措施: measurement of myokines (Diagnostic Test)

ICU patients

Experimental

Lab and clinical investigations to characterize the metabolic and muscle profile

干预措施: Resting energy expendure (Diagnostic Test)

ICU patients

Experimental

Lab and clinical investigations to characterize the metabolic and muscle profile

干预措施: body composition (Diagnostic Test)

ICU patients

Experimental

Lab and clinical investigations to characterize the metabolic and muscle profile

干预措施: Omics (Diagnostic Test)

ICU patients

Experimental

Lab and clinical investigations to characterize the metabolic and muscle profile

干预措施: Monocyte profile (Diagnostic Test)

Surgical patients

Active Comparator

Lab and clinical investigations to characterize the metabolic and muscle profile

干预措施: Inflammation markers (Diagnostic Test)

Surgical patients

Active Comparator

Lab and clinical investigations to characterize the metabolic and muscle profile

干预措施: Blood nucleosomes (Diagnostic Test)

Surgical patients

Active Comparator

Lab and clinical investigations to characterize the metabolic and muscle profile

干预措施: Erythrocyte membrane fatty acid content (Diagnostic Test)

Surgical patients

Active Comparator

Lab and clinical investigations to characterize the metabolic and muscle profile

干预措施: measurement of myokines (Diagnostic Test)

Surgical patients

Active Comparator

Lab and clinical investigations to characterize the metabolic and muscle profile

干预措施: Resting energy expendure (Diagnostic Test)

Surgical patients

Active Comparator

Lab and clinical investigations to characterize the metabolic and muscle profile

干预措施: body composition (Diagnostic Test)

Surgical patients

Active Comparator

Lab and clinical investigations to characterize the metabolic and muscle profile

干预措施: Omics (Diagnostic Test)

Surgical patients

Active Comparator

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

发起方
Anne-Françoise Rousseau
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Anne-Françoise Rousseau

Associate Professor

University of Liege

研究点 (1)

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