RecruitingPhase 2NCT06065202

Personalized Nutrition to Improve Recovery in Trauma

Personalized Targeted Nutrition Via StructurEd Nutrition Delivery Pathway to Improve Recovery of Physical Function in Trauma


Sponsor

Duke University

Enrollment

150 participants

Start Date

Apr 12, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 15 Years

Inclusion Criteria4

  • + 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 Criteria4

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIETARY_SUPPLEMENTNutrition Supplement

Total parenteral nutrition (TPN) will be administered within 72 hours of abdominal surgery. Nutritional shakes will be started with a liquid diet and given 3 times a day. This will continue for 4 weeks after discharge.


Locations(1)

Duke University Hospital

Durham, North Carolina, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06065202


Related Trials