Actively Recruiting
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
Eligibility Criteria
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
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- Expected to have life support withdrawn within 48 hours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
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Trial Site Locations
Total: 1 location
1
Duke University Hospital
Durham, North Carolina, United States, 27710
Actively Recruiting
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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