Evaluation of Effectiveness of Combining High Protein Intake With Early Physical Exercise During Critical Illness to Maintain Muscle Mass in Intensive Care Unite Patient.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Quantitative changes (cross-section diameter) of rectus femoris muscle
研究概览
简要总结
Assessment of Effectiveness of combined high protein intake with early physical exercise by ultrasound measurement of rectus femoris muscle thickness in Intensive Care Unite mechanically ventilated patients.
详细描述
Muscle wasting and weakness is a frequent finding in critically ill patients and is associated with worse short- and long-term outcomes like delayed liberation from mechanical ventilation, longer Intensive Care Unit and hospital stay, worse physical function and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in age group 18-60 years
- •Expected Intensive Care Unit stay >4days after enrolment (to permit adequate exposure to the proposed intervention)
- •Previously healthy, Well-nourished, subjects (nutric score=0)
排除标准
- •Renal, liver or heart disease or chronic obstructive pulmonary disease
- •Previous immune abnormalities (including treatment with corticosteroids)
- •Past history of nutritional problems, chronic use of drugs (as drugs inducing myopathies) or orthopedic problems (such as skeletal fractures or immobilization) in the previous 2 years
- •Neuromuscular diseases and patients with amputated lower limbs
- •Past or recent history of cancer
- •Long term critically ill patients shifted from other hospitals
- •Pregnant patients
研究组 & 干预措施
Standard care
Patients will receive usual care in Intensive Care Unit (prescription of a standard nutrition formula (at approximately 20 -25 kcal/ kg/day and protein intake 1.2 g/kg/day) once patients are hemodynamically stable.
干预措施: Amino Acid (Drug)
Protein and exercise group
patients will receive the amino acid intervention that is provided in addition to 'usual care' enteral and/or parenteral nutrition either enteral or parenteral to target a total protein delivery of 2.0g/kg/day. The physical exercise intervention will be delivered by trained nursing staff, and started as close to the time of randomization as feasible (within 24hours of randomization). The intervention group will receive exercise sessions, for up to 20 min duration (as tolerated by patient). The implementation of physical exercise intervention will be protocolized to provide passive exercise early before weaning and shift to active exercise after weaning and also graduated resistance during each session and between daily sessions.
干预措施: Amino Acid (Drug)
Protein and exercise group
patients will receive the amino acid intervention that is provided in addition to 'usual care' enteral and/or parenteral nutrition either enteral or parenteral to target a total protein delivery of 2.0g/kg/day. The physical exercise intervention will be delivered by trained nursing staff, and started as close to the time of randomization as feasible (within 24hours of randomization). The intervention group will receive exercise sessions, for up to 20 min duration (as tolerated by patient). The implementation of physical exercise intervention will be protocolized to provide passive exercise early before weaning and shift to active exercise after weaning and also graduated resistance during each session and between daily sessions.
干预措施: Physical exercise (Procedure)
结局指标
主要结局
Quantitative changes (cross-section diameter) of rectus femoris muscle
时间窗: Up to 30 days of Surgical Intensive Care Unit stay.
Rectus femoris cross-sectional area (RFCSA) will be measured by B-mode ultrasonography using a 3 to 12 MHz transducer array. Patient will be positioned supine in 30° upper body elevation, with legs extended and muscles relaxed. The point that represented 60% of the distance from the anterior superior iliac spine to the superior border of the patella will be identified. The ultrasound probe will be positioned perpendicularly along the superior aspect of the right thigh and transverse images of the rectus femoris will be obtained. A copious amount of gel will be applied to minimize tissue compression. The inner echogenic line of the Rectus Femoris will be traced manually on a frozen image and RFCSA will be calculated by planimetric technique.
次要结局
- Functional capacity.(Up to 30 days of Surgical Intensive Care Unit stay.)
- Length of Surgical Intensive Care Unit stay.(Up to 30 days)
- Duration of mechanical ventilation.(Up to 30 days of Surgical Intensive Care Unit stay.)
- Mortality rate in Surgical Intensive Care Unit(Up to 30 days)
- Rate of hospital acquired infection.(Up to 30 days)
研究者
Asmaa Badr Eldin
Doctor Asmaa Badr Eldin
Tanta University