Personalized Nutrition to Improve Recovery in Trauma

NCT06065202 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: Pro00112343
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if a particular method of providing nutrition improves the outcomes of patients in the intensive care unit (ICU) who have undergone abdominal surgery following trauma and would require nutrition delivered via the bloodstream (called total parenteral nutrition or TPN). The nutrition method being tested is a structured nutrition delivery plan, called the SeND Home pathway, that involves TPN, oral nutrition supplements, and the use of a device (called an indirect calorimeter or IC) to measure calorie needs. Participants will be randomly assigned (like the flip of a coin) to the SeND Home program or standard of care nutrition. In the SeND Home program, participants will receive TPN, followed by oral nutrition supplements (shakes) for 4 weeks after discharge. The control group will follow standard of care nutrition delivery that begins during ICU stay and concludes at hospital discharge. Participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass and complete walking and strength tests, and surveys about quality of life.

Conditions

Abdominal Trauma

Keywords

precision nutrition; critical care; trauma; parenteral nutrition; indirect calorimetry

Outcome Measures

Primary Outcomes (1)

• Change in six-minute walk distance (6 MWD)

  Change in 6MWD from baseline to day 14 or hospital discharge will be compared between the two study arms

  3 months

Secondary Outcomes (10)

• Change in physical function

  baseline, day 14 or hospital discharge, 3 and 6 months post-hospital discharge

• Change in muscle strength

  baseline, hospital discharge, 3 and 6 months post-hospital discharge

• Change in muscle mass

  baseline, hospital discharge, 3 and 6 months post-hospital discharge

• Change in Quality of Life (QoL)

  baseline, 3 and 6 months post-hospital discharge

• Change in cognition

  baseline, 3 and 6 months post-hospital discharge

Study Arms (2)

SeND Home Pathway

EXPERIMENTAL

Total parenteral nutrition (TPN) will begin within 72 hours of abdominal surgery. Calorie needs will be determined by indirect calorimetry. Nutritional shakes will begin when a liquid diet is started. These will be taken 3 times a day while in the hospital and for 4 weeks after discharge.

Dietary Supplement: Nutrition Supplement

Standard Nutrition

NO INTERVENTION

Standard nutrition as determined by clinical providers.

Interventions

Nutrition Supplement DIETARY_SUPPLEMENT

Total parenteral nutrition (TPN) will be administered within 72 hours of abdominal surgery. Nutritional shakes will be started with a liquid diet and given 3 times a day. This will continue for 4 weeks after discharge.

Also known as: CLINIMIX E 8/14 sulfite-free, CLINOLIPID 20%, Nutritional shakes

SeND Home Pathway

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• + years old
• Penetrating abdominal trauma requiring emergent major abdominal surgery
• Admitted to the surgical ICU
• Not expected to receive oral nutrition for 72 hours or more

You may not qualify if:

• Patients who are unable to ambulate at baseline
• Expected withdrawal of life-sustaining treatment within 48 hours
• Prisoners
• Positive pregnancy test for women of child bearing potential.

Sponsors & Collaborators

• Duke University: lead
• United States Department of Defense: collaborator
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Abdominal Injuries; Wounds and Injuries; Hyperphagia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul Wischmeyer, MD

  Duke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Krista Haines, MD

CONTACT

919-681-3784; krista.haines@duke.edu

Hilary Winthrop

CONTACT

919-668-7238; hilary.winthrop@duke.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 3, 2023
• Study Start: April 12, 2024
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 6, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)