Optimizing Recovery in Trauma Patients by Integrating Enhanced Nutrition Delivery

Duke University

Status: Begins enrollment in 1 month

Conditions: Trauma; Critical Illness

Treatments: Dietary Supplement: Nutrition Supplements - Fresubin KCAL Drinks

Study type: Interventional

Funder types: Other

Identifiers

NCT06521086

Pro00114950

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Enhanced Protein Supplementation

Experimental group

Description:

Oral nutrition supplements (ONS) will be given, at maximum, three times per day throughout hospitalization. Upon discharge, participants will be given 4-weeks' worth of oral supplements to take. Adjustments may be made based on indirect calorimetry (IC) measurements.

Treatment:

Dietary Supplement: Nutrition Supplements - Fresubin KCAL Drinks

Control Pathway

No Intervention group

Description:

Standard of care nutrition delivery throughout hospitalization. Upon discharge participants will be sent home with standard nutrition information without Indirect Calorimetry (IC) guidance.