Optimizing Recovery in Trauma Patients: Integrating Enhanced Nutrition Delivery With Muscle Assessments, Functional Outcomes and Quality of Life
Overview
- Phase
- N/A
- Intervention
- Nutrition Supplements - Fresubin KCAL Drinks
- Conditions
- Trauma
- Sponsor
- Duke University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in glycogen stores as a measure of muscle quality
- Status
- Not Yet Recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: Nutrition Supplements - Fresubin KCAL Drinks
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.
Outcomes
Primary Outcomes
Change in glycogen stores as a measure of muscle quality
Time Frame: Baseline to one month post-discharge (approximately six weeks)
Change in muscle mass as a measure of muscle quality
Time Frame: 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
Time Frame: Baseline to one month post-discharge (approximately six weeks)
Body composition is the percentage of a body's weight that is fat tissue.
Secondary Outcomes
- 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))