Duke University Hospital
Durham, North Carolina, 27710, United States
Location status: Recruiting
NCT Number: NCT06521086
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.
Interested in participating?
Request Info45 year and older
All sexes
Interventional
Not applicable
Durham, North Carolina, 27710, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fresubin drinks will be taken up to 3 times a day throughout hospitalization and for 4 weeks after discharge.
Time frame: Baseline to one month post-discharge (approximately six weeks)
Time frame: Baseline to one month post-discharge (approximately six weeks)
Time frame: Baseline to one month post-discharge (approximately six weeks)
Body composition is the percentage of a body's weight that is fat tissue.
Time frame: Baseline to one month post-discharge (approximately six weeks)
The 6MWT assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.
Time frame: Baseline to one month post-discharge (approximately six weeks)
Four meter gait speed is the time one takes to walk four meters on a level surface.
Time frame: Baseline to one month post-discharge (approximately six weeks)
This test measures the number of times an individual can stand from a chair with no assistance in 30 seconds. This test is used to assess functional lower body strength.
Time frame: Baseline to one month post-discharge (approximately six weeks)
Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It can be used as a screening tool for the measurement of upper body strength and overall strength.
Time frame: Baseline to one month post-discharge (approximately six weeks)
ED (electromechanical dynamometry) can be used in either isometric or isokinetic mode. Quadriceps strength is expressed as peak knee extensor torque, which is produced at around 60° knee flexion.
Contact information is provided by the study sponsor or research team.
Krista Haines, MD
CONTACT
Paul Wischmeyer, MD
CONTACT
Duke University
Other
Optimizing Recovery in Trauma Patients: Integrating Enhanced Nutrition Delivery With Muscle Assessments, Functional Outcomes and Quality of Life
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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