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Recruiting
NCT06521086
Optimizing Recovery in Trauma Patients by Integrating Enhanced Nutrition Delivery
Conditions: Trauma, Critical Illness
Sex: All
Ages: 45 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Duke University
Location: Duke University Hospital Durham North Carolina
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.
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.
* Prisoner
* Pregnancy for women of child-bearing potential
Source: ClinicalTrials.gov (NCT06521086). StuddyBuddy aggregates publicly available trial information.
