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临床试验/NCT06168136
NCT06168136尚未招募不适用

Effects of Medical High Protein Nutrition on the Muscle Mass in Adult ICU Patients

Assiut University0 个研究点目标入组 84 人开始时间: 2024年1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
84
主要终点
Monitoring muscle mass changes in response to high protein intake

研究概览

简要总结

The use of ultrasound in clinical practice is feasible for monitoring muscle mass in critically ill patients. Assessment of muscle mass by ultrasound is clinically relevant and adds value for guiding therapeutic interventions, such as nutritional and physical therapy interventions to maintain muscle mass and promote recovery in critically ill patients.

详细描述

Critical illness is characterized by substantial hormone- and cytokine-mediated protein metabolism changes in various organs, leading to increased breakdown and decreased synthesis rates. Consequently, a considerable and life-threatening loss of muscle mass occurs. Medical therapeutic measures such as long-term sedation and mechanical ventilation during ICU stay can further enhance this muscle degradation (up to 2 % muscle mass per day leading to clinically relevant symptoms known as ICU-acquired weakness. Nutritional modulation, particularly of dietary amino acids, may have benefits to prevent or attenuate disease-induced muscle wasting. while there are several accurate muscle mass measurement methods and techniques [including computed tomography (CT) scan, bio-impedance analysis and ultrasound], not all are routinely feasible in clinical ICU practice. The use of ultrasound in assessing muscle mass in critically ill patients has gained much attention recently as it is non-invasive and can easily be utilized at the bedside. There are two main goals for the assessment of muscle mass: first, to assess the current muscle mass for the patient as part of (nutritional) diagnosis, and thereby risk stratification and second, to monitor the progression of muscle loss and/or recovery of muscle mass, and create opportunity to examine the effectiveness of therapeutic interventions to reduce muscle loss and/or promote muscle recovery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

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

  • all critically ill-patients with Acute Physiologic Assessment and Chronic Health Evaluation II (8) (APACHE II score ) ≥ 25 and could be enterally or parenterally fed in the critical care unit of Assiut University Hospitals.

排除标准

  • patients with malabsorption syndrome, previously diagnosed myopathies, traumatic brain injuries, intracerebral hemorrhages and cerebral ischemia.

结局指标

主要结局

Monitoring muscle mass changes in response to high protein intake

时间窗: one year

muscle mass using ultrasound and laboratory: titre of CK (Creatinine kinase) level.

次要结局

  • - Duration of mechanical ventilation in days. - Improvement of APACHE II score. - Duration of hospital stay in days. - Early ambulation of patients in days. - In hospital mortality.(one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Esam

Principal investigator

Assiut University

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