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临床试验/NCT06012201
NCT06012201尚未招募不适用

Relationship Between Protein Intake and ICU Skeletal Muscle Weakness

Tufts Medical Center0 个研究点目标入组 60 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
the percentage of reduction in the muscle mass measured by US.

研究概览

简要总结

Muscle wasting is a common finding in critically ill patients and is associated with adverse outcomes. A good strategy for avoiding or decreasing muscle loss is adding adequate quantities of protein to the nutritional therapy administered during the acute phase of the disease during the ICU stay. The aim of this prospective study is to compare the effect of different levels of protein enteral feeding on Rectus Femoris Muscle mass in mechanically ventilated patients.

详细描述

Muscle wasting is a common finding in critically ill patients and is associated with adverse outcomes. Loss of mass and function of skeletal muscles start early in the first 24 h after admission and may persist for years (post-ICU syndrome).

It is a major cause of ICU-acquired muscle weakness and is associated with delayed weaning, prolonged ICU and hospital stay, and is an independent predictor of 1-year mortality.

Long-term muscle impairment affects the quality of life of ICU survivors as it is responsible for physical, mental, and cognitive dysfunction and increases the costs of health care services.

Trauma is always associated with stress leading to multisystem alterations, changes in macronutrient metabolism, as well as endocrine-metabolic activities, and immunological responses.

The stress response increases energy expenditure (EE) and the use of protein reserves. The mobilization of these reserves is not a unidirectional catabolic process but it results in an imbalance between protein synthesis and degradation depending on the magnitude of the trauma.

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 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients of both sexes, 18-50 years old with a Glasgow Coma Scale ≤ 8 and an injury severity score (ISS>15) were admitted to our ICU within 24 hours after the injury. only well-nourished ( Modified Nutric -Score for Risk Screening = 0- 4), previously healthy subjects will be recruited.

排除标准

  • Pregnancy, Patients with BMI ≥ 35,
  • Vascular insufficiency or trauma to the lower limbs,
  • History of neuromuscular diseases, Prolonged immobility prior to ICU admission,
  • Comorbidities (renal, hepatic, cardiac disorders, chronic obstructive pulmonary disease, and diabetic patient),
  • Patients with malignant diseases or immune disorders,
  • Prolonged corticosteroids (CS) or neuromuscular blocking agents (NMBA) use,
  • ARDS patient (P/F ratio ≤ 200), Sepsis, Multiorgan failure.

结局指标

主要结局

the percentage of reduction in the muscle mass measured by US.

时间窗: day 0 , 1, and 5 days of ICU admission

the percentage of muscle mass change compared to the other group

次要结局

  • age in years(at the baseline day (0) of study)
  • Echogenicity by Heckmatt scale(day 0 , 1, and 5 days of ICU admission)
  • weight in kilograms(at the baseline day (0) of study)
  • Body Mass index in Kilogram/meter square(at the baseline day (0) of study)
  • Serum albumin and total protein in grams per deciliter(day 0 , 1, and 5 days of ICU admission)
  • Pennation angle of rectus femoris muscle in degrees(day 0 , 1, and 5 days of ICU admission)
  • Length of mechanical ventilation and ICU stay in days(until discharge or died)
  • sex predominance in each group(at the baseline day (0) of study)
  • modified nutric score(at the baseline day (0) of study)
  • cross- sectional area in centimeter(day 0 , 1, and 5 days of ICU admission)
  • Blood urea nitrogen in mg/dL(at baseline day (0) then at day 1 st, 5th after initiation of nutritional therapy..)
  • nitrogen balance in gram per day(at baseline day (0) then at day 1 st, 5th after initiation of nutritional therapy.)

研究者

申办方类型
Other
责任方
Sponsor

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