Optimizing Recovery in Trauma Patients: Integrating Enhanced Nutrition Delivery With Muscle Assessments, Functional Outcomes and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in glycogen stores as a measure of muscle quality
研究概览
简要总结
This is a prospective, randomized, controlled trial designed to evaluate the impact of enhanced protein supplementation compared to a standard of care nutrition delivery in critically ill older adult trauma patients. Subjects will be randomized 1:1 to either enhanced nutrition or control arm. Subjects randomized to the enhanced nutrition arm will receive oral nutrition supplements (ONS) up to 3 times per day while in the hospital and for 4 weeks after discharge. Subjects in the standard of care arm will receive normal nutrition recommendations from their clinical providers. Participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass.
详细描述
This is a prospective, randomized, controlled trial designed to evaluate the impact of enhanced protein supplementation compared to a standard of care nutrition delivery in critically ill older adult trauma patients. Enhanced protein supplementation supports patients from ICU admission to 4-weeks post-hospital discharge, providing a comprehensive and personalized plan of care carried to completion.
Subjects will be randomized 1:1 to enhanced nutrition or control arm. Subjects randomized enhanced nutrition oral nutrition supplements (Fresenius KCAL shakes) up to 3 times per day while in the hospital and for 4 weeks after discharge. Subjects in the standard of care arm will receive normal nutrition recommendations from their clinical providers.
Participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass. They will also be asked to complete walking and strength tests, and surveys about quality of life.These will be done at hospital admission, day 14 or hospital discharge, and at a one month post-discharge follow-up visit.
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
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are at least 45 years old and presented to the Emergency Department as a leveled trauma
- •Patients who have the ability to tolerate oral nutrition
- •Patients who have had a standard of care CT scan this admission
排除标准
- •Expected withdrawal of life-sustaining treatment within 48 hours
- •Traumatic Brain Injury
- •Presence of lower extremity fracture(s)
- •Mechanical Ventilation
- •Subjects for who the Investigator would recommend a different supplement based on their medical condition.
- •Pregnancy for women of child-bearing potential
研究组 & 干预措施
Control Pathway
Standard of care nutrition delivery throughout hospitalization. Upon discharge participants will be sent home with standard nutrition information without Indirect Calorimetry (IC) guidance.
Enhanced Protein Supplementation
Oral nutrition supplements (ONS) will be given, at maximum, three times per day throughout hospitalization. Upon discharge, participants will be given 4-weeks' worth of oral supplements to take. Adjustments may be made based on indirect calorimetry (IC) measurements.
干预措施: Nutrition Supplements - Fresubin KCAL Drinks (Dietary Supplement)
结局指标
主要结局
Change in glycogen stores as a measure of muscle quality
时间窗: Baseline to one month post-discharge (approximately six weeks)
Change in muscle mass as a measure of muscle quality
时间窗: Baseline to one month post-discharge (approximately six weeks)
Change in body composition (percentage of a body's weight that is fat tissue) as a measure of muscle quality
时间窗: Baseline to one month post-discharge (approximately six weeks)
Body composition is the percentage of a body's weight that is fat tissue.
次要结局
- Change in six minute walk test (6MWT) distance(Baseline to one month post-discharge (approximately six weeks))
- Change in quadriceps strength(Baseline to one month post-discharge (approximately six weeks))
- Change in four meter gait speed(Baseline to one month post-discharge (approximately six weeks))
- Change in 30-second sit to stand test(Baseline to one month post-discharge (approximately six weeks))
- Change in grip strength(Baseline to one month post-discharge (approximately six weeks))