Optimizing Recovery in Trauma Patients by Integrating Enhanced Nutrition Delivery

Not Applicable

Not yet recruiting

• Conditions: Trauma; Critical Illness
• Interventions: Dietary Supplement: Nutrition Supplements - Fresubin KCAL Drinks

• Registration Number: NCT06521086
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2024-05-03
• Study First Submitted QC: 2024-07-22
• Study First Posted: 2024-07-25
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-02-28
• Study Start: 2025-06-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.
• Prisoner
• Pregnancy for women of child-bearing potential

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Protein Supplementation	Nutrition Supplements - Fresubin KCAL Drinks	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.

Primary Outcome Measures

Name	Time	Method
Change in glycogen stores as a measure of muscle quality	Baseline to one month post-discharge (approximately six weeks)
Change in muscle mass as a measure of muscle quality	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	Baseline to one month post-discharge (approximately six weeks)	Body composition is the percentage of a body's weight that is fat tissue.

Secondary Outcome Measures

Name	Time	Method
Change in six minute walk test (6MWT) distance	Baseline to one month post-discharge (approximately six weeks)	The 6MWT assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.
Change in quadriceps strength	Baseline to one month post-discharge (approximately six weeks)	ED (electromechanical dynamometry) can be used in either isometric or isokinetic mode. Quadriceps strength is expressed as peak knee extensor torque, which is produced at around 60° knee flexion.
Change in four meter gait speed	Baseline to one month post-discharge (approximately six weeks)	Four meter gait speed is the time one takes to walk four meters on a level surface.
Change in 30-second sit to stand test	Baseline to one month post-discharge (approximately six weeks)	This test measures the number of times an individual can stand from a chair with no assistance in 30 seconds. This test is used to assess functional lower body strength.
Change in grip strength	Baseline to one month post-discharge (approximately six weeks)	Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It can be used as a screening tool for the measurement of upper body strength and overall strength.

Trial Locations

Locations (1)

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States