Recruiting
Phase 2

Personalized Nutrition

Sponsor:

Duke University

Code:

NCT06065202

Conditions

Abdominal Trauma

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Not accepted

Interventions

Nutrition Supplement

Study Details

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

Study ID

NCT06065202

Start date

Apr 12, 2024

Status verified date

Nov, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Mar 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 15+ 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SeND Home Pathway

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.

no intervention: Standard Nutrition

Standard nutrition as determined by clinical providers.

Interventions

Nutrition 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.

Primary outcome measure

  • Change in six-minute walk distance (6 MWD) [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Locations

Duke University Hospital

Recruiting

Durham, North Carolina, United States, 27710

Contacts

More Information

Sponsor

Duke University

Last update posted

May 6, 2026

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-05-06.