Clinical trial NCT06521086: Optimizing Recovery in Trauma Patients by Integrating Enhanced Nutrition Delivery
Official title: Optimizing Recovery in Trauma Patients: Integrating Enhanced Nutrition Delivery With Muscle Assessments, Functional Outcomes and Quality of Life
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Trauma
Critical Illness
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in muscle mass as a measure of muscle quality
timeFrame: Baseline to one month post-discharge (approximately six weeks)
measure: Change in glycogen stores as a measure of muscle quality
timeFrame: Baseline to one month post-discharge (approximately six weeks)
measure: Change in body composition (percentage of a body's weight that is fat tissue) as a measure of muscle quality
timeFrame: Baseline to one month post-discharge (approximately six weeks)
Secondary outcomes:
measure: Change in six minute walk test (6MWT) distance
timeFrame: Baseline to one month post-discharge (approximately six weeks)
measure: Change in four meter gait speed
timeFrame: Baseline to one month post-discharge (approximately six weeks)
measure: Change in 30-second sit to stand test
timeFrame: Baseline to one month post-discharge (approximately six weeks)
measure: Change in grip strength
timeFrame: Baseline to one month post-discharge (approximately six weeks)
measure: Change in quadriceps strength
timeFrame: Baseline to one month post-discharge (approximately six weeks)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
affiliation: Duke University
name: Paul Wischmeyer, MD
role: PRINCIPAL_INVESTIGATOR
References: