Personalized Nutrition to Improve Recovery in Trauma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age15+
SponsorDuke University

About this trial

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

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Nutrition Supplement

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Duke University

Lead sponsor

United States Department of Defense

Collaborator

Baxter Healthcare Corporation

Collaborator