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Optimizing Recovery in Trauma Patients by Integrating Enhanced Nutrition Delivery

RecruitingNAAges 45 Years - anyAllDuke University
NCT06521086 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Nutrition Supplements - Fresubin KCAL Drinks
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Where

1 site
Duke University Hospital
Durham, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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