Personalized nutrition to help recovery after abdominal trauma
Official title: Personalized Targeted Nutrition Via StructurEd Nutrition Delivery Pathway to Improve Recovery of Physical Function in Trauma
Run by Duke University · NCT06065202 · Data updated 2026-11-12
This study is testing if a personalized nutrition plan can help ICU patients recover better after abdominal surgery from trauma compared to standard nutrition care.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 15 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | April 12, 2024 |
| Main results expected | March 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | May 6, 2026 |
| Trial ID | NCT06065202 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with penetrating abdominal trauma requiring major surgery and who cannot receive oral nutrition for at least 72 hours.
✕Probably not a fit
Patients who are unable to ambulate at baseline or those expected to withdraw life-sustaining treatment within 48 hours may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates whether a structured nutrition delivery plan improves recovery outcomes for ICU patients who have undergone abdominal surgery due to trauma. Participants will be randomly assigned to either the SeND Home program, which includes total parenteral nutrition (TPN) and oral nutrition supplements, or to standard care nutrition. The SeND Home program aims to provide tailored nutritional support starting within 72 hours post-surgery, utilizing indirect calorimetry to assess individual calorie needs. Participants will undergo various assessments to measure muscle mass, strength, and quality of life throughout their hospitalization and during follow-up.
Why it matters
Potential benefit: If successful, this approach could significantly enhance recovery and quality of life for trauma patients after abdominal surgery.
How similar studies have gone: While the approach of personalized nutrition in trauma recovery is gaining attention, this specific methodology is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Duke University Hospital
Durham, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Paul Wischmeyer, MD — Duke
- Study coordinator: Krista Haines, MD
- Email: krista.haines@duke.edu
- Phone: 919-681-3784
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.