Optimizing Recovery in Trauma Patients by Integrating Enhanced Nutrition Delivery

NCT ID: NCT06521086

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-01-30

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.

Conditions

Trauma; Critical Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Enhanced Protein Supplementation

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.

Group Type: EXPERIMENTAL

Nutrition Supplements - Fresubin KCAL Drinks

Intervention Type: DIETARY_SUPPLEMENT

Fresubin drinks will be taken up to 3 times a day throughout hospitalization and for 4 weeks after discharge.

Control Pathway

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nutrition Supplements - Fresubin KCAL Drinks

Fresubin drinks will be taken up to 3 times a day throughout hospitalization and for 4 weeks after discharge.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Wischmeyer, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Hospital

Durham, North Carolina, United States

Countries

United States

Central Contacts

Paul Wischmeyer, MD

Role: CONTACT

paul.wischmeyer@duke.edu

919-681-9660

Krista Haines, MD

Role: CONTACT

krista.haines@duke.edu

919-681-3784

Other Identifiers

Pro00114950

Identifier Type: -

Identifier Source: org_study_id