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NCT06521086 | NOT YET RECRUITING | Trauma

Optimizing Recovery in Trauma Patients by Integrating Enhanced Nutrition Delivery
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.

Condition or disease

Trauma

Critical Illness

Intervention/treatment

Nutrition Supplements - Fresubin KCAL Drinks

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : Optimizing Recovery in Trauma Patients: Integrating Enhanced Nutrition Delivery With Muscle Assessments, Functional Outcomes and Quality of Life
Actual Study Start Date : 2025-06-01
Estimated Primary Completion Date : 2026-06-30
Estimated Study Completion Date : 2026-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 45 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Optimizing Recovery in Trauma Patients by Integrating Enhanced Nutrition Delivery

Location Details

NCT06521086

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, North Carolina

Duke University Hospital

Durham, North Carolina, United States, 27710