NCT06065202 Personalized Nutrition to Improve Recovery in Trauma
| NCT ID | NCT06065202 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Duke University |
| Condition | Abdominal Trauma |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-04-12 |
| Primary Completion | 2027-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 150 participants in total. It began in 2024-04-12 with a primary completion date of 2027-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Paul Wischmeyer, MD
PRINCIPAL INVESTIGATOR
Duke
Frequently Asked Questions
Who can join the NCT06065202 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, studying Abdominal Trauma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06065202 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06065202 currently recruiting?
Yes, NCT06065202 is actively recruiting participants. Contact the research team at krista.haines@duke.edu for enrollment information.
Where is the NCT06065202 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT06065202 clinical trial?
NCT06065202 is sponsored by Duke University. The principal investigator is Paul Wischmeyer, MD at Duke. The trial plans to enroll 150 participants.