Actively Recruiting

Phase 2
Age: 15Years +
All Genders
NCT06065202

Personalized Nutrition to Improve Recovery in Trauma

Led by Duke University · Updated on 2026-05-06

150

Participants Needed

1

Research Sites

167 weeks

Total Duration

On this page

Sponsors

D

Duke University

Lead Sponsor

U

United States Department of Defense

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Personalized Nutrition to Improve Recovery in Trauma

Who Can Participate

Age: 15Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 15 years or older
  • Penetrating abdominal trauma requiring major emergency abdominal surgery
  • Admission to the surgical intensive care unit (ICU)
  • Not expected to receive oral nutrition for 72 hours or more after surgery
Not Eligible

You will not qualify if you...

  • Unable to walk before the injury
  • Expected to have life support withdrawn within 48 hours
  • Prisoner status
  • Positive pregnancy test for women who can become pregnant

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Duke University Hospital

Durham, North Carolina, United States, 27710

Actively Recruiting

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Research Team

K

Krista Haines, MD

CONTACT

H

Hilary Winthrop

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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