Effects of Omega-3 Fatty Acids on Sarcopenia in Trauma Patients in Intensive Care Unit
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Changes in triceps and biceps skinfold thickness Changes in triceps and biceps skinfold thickness
研究概览
简要总结
The risk of muscle wasting, and sarcopenia is high in the intensive care unit patients and associated with adverse clinical outcomes. The etiology of muscle wasting is multifactorial and medical nutrition therapy plays a key role in treatment and prevention. The purpose of this study is to evaluate the effect of omega-3 fatty acids in the treatment and/or prevention of muscle wasting in critically ill trauma patients.
详细描述
Low skeletal muscle mass and loss of lean tissue in critically illness have been associated with negative clinical outcomes. Critically ill patients may lose about 25% of their skeletal muscle mass within 7 days of admission to the intensive care unit. Besides increased protein catabolism, other factors inherent to the ICU environment contribute to muscle loss, including patient immobility and interruptions in nutrient delivery. This combination of factors is especially debilitating in patients with preexisting low muscle stores due to sarcopenia, chronic illness, or malnutrition. Although preservation of skeletal muscle mass is important for recovery in critically ill patients, the mechanism of muscle wasting is not unknown. Muscle wasting is a multifactorial process and it may be the consequence of several events, including oxidative stress, inflammatory conditions and muscle remodeling. Omega-3 fatty acids with their anti-inflammatory, antioxidant and anabolic effects can be a key factor for an effective treatment.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years and ≤80 years, Expected ICU stay of seven days or longer Written informed consent or requirements of local/national ethical committee
排除标准
- •Pregnancy or breastfeeding Neuromuscular conditions (e.g., multiple sclerosis, muscular dystrophy, spinal cord injury, Guillain-Barre syndrome) Current cancer or chemotherapy End-stage of renal failure or dialysis treatment or renal transplantation prior to ICU admission Burn injury History of transplantation Pretibial edema Uncontrolled hemorrhage Uncontrolled hyperlipidemia Acute pancreatitis Acute thromboembolic diseases Severe heart failure Septic shock Concurrent enrolment in a nutrition-related interventional study at the time of screening
结局指标
主要结局
Changes in triceps and biceps skinfold thickness Changes in triceps and biceps skinfold thickness
时间窗: Baseline and 7 days
Will be measured by caliper.
Changes in mid-upper arm and calf circumferences
时间窗: Baseline and 7 days
Will be measured by tape measure.
Changes in biochemical parameters related to muscle homeostasis, oxidative stress and inflammation
时间窗: Baseline and 7 days
Biochemical parameters related to muscle wasting such as TNF-a, IL-6, TOS, P3NP
Changes in rectus femoris muscle cross-sectional area
时间窗: Baseline and 7 days
Will be evaluated by ultrasound.
次要结局
- Intensive care unit length of stay(Time of admission to the ICU until the time of discharge from the intensive care unit, up to 1 year)
- Hospital Length of Stay(Time of discharge from the ICU until hospital discharge, up to 1 year)
- 28-day mortality(28 day)
研究者
Hulya ULUSOY
Clinical Professor
Karadeniz Technical University