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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Nutrition Supplement
Dietary supplementTotal 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.
Treatment groups
Trial outcomes
Primary outcomes
Change in six-minute walk distance (6 MWD)
Change in 6MWD from baseline to day 14 or hospital discharge will be compared between the two study arms
Secondary outcomes
Change in physical function
This will be measured by comparing the changes in physical function tests (4 meter walk, sit-to-stand) between the two study arms.
Change in muscle strength
This will be measured by comparing the changes in grip and quad strength tests between the two study arms.
Change in muscle mass
This will be measured by comparing changes in bioelectrical impedance analysis (BIA) between the two study arms.
Change in Quality of Life (QoL)
This will be measured by comparing changes in the EuroQoL-5 Dimension and 43-item Trauma Specific Quality of Life measurement between the two study arms.
Sponsors and contacts
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Duke University
Lead sponsor
United States Department of Defense
Collaborator
Baxter Healthcare Corporation
Collaborator