Home › Hyperphagia › NCT06065202
Personalized Nutrition to Improve Recovery in Trauma
Personalized Targeted Nutrition Via StructurEd Nutrition Delivery Pathway to Improve Recovery of Physical Function in Trauma
Who can join
Ages 15 and older · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- Nutrition Supplement (dietary supplement)
Sponsor: Duke University · Participants: 150 · Started: Apr 12, 2024
Contact the study team
- Krista Haines, MD · Phone: 919-681-3784
- Hilary Winthrop · Phone: 919-668-7238
Official record on ClinicalTrials.gov — NCT06065202
Locations in the U.S.
| North Carolina | Duke University Hospital, Durham |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.