Personalized Nutrition to Improve Recovery in Trauma
Recruiting now · Phase 2
Conditions studied: Abdominal Trauma
In brief
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.
Key facts
- Study ID
- NCT06065202
- Run by
- Duke University
- People needed
- 150
- Starts
- 2024-04-12
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2026-05-06
Who can join
Age: 15 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
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.
Where it is running
- Duke University Hospital — Durham, North Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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