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NCT06521086NARecruiting

Optimizing Recovery in Trauma Patients by Integrating Enhanced Nutrition Delivery

Duke University

Start Date

2/18/2026

Completion Date

5/30/2028

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.

Eligibility Criteria

Age Range: 45 years to No maximum

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

Interventions

DIETARY_SUPPLEMENT

Nutrition Supplements - Fresubin KCAL Drinks

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Conditions

TraumaCritical Illness

Locations

Duke University Hospital

Durham, North Carolina 27710

United States