A Phase 2 interventional study of Nutrition Supplement in Abdominal Trauma, sponsored by Duke University. Recruiting at 1 site in United States. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Duke University · Phase 2, Interventional, and Treatment
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.
Severe abdominal trauma can impact patients in a variety of ways. Current data shows that trauma patients can experience problems with physical function, muscle weakness, and poor quality of life after they are released from the hospital. There is a critical need to improve nutrition in trauma patients with severe abdominal injuries to optimize the recovery process. The purpose of this study is to evaluate if the use of a planned nutrition delivery plan with early intravenous (IV) nutrition will improve outcomes. Participants will be randomly assigned 1:1, like flipping a coin, to the SeND Home program or routine care.
Participants in the standard of care program will receive standard nutrition delivery as determined by clinical care providers. This may include TPN.
Participants in the SeND Home program will receive TPN within 72 hours of abdominal surgery. Indirect calorimetry will be used to determine nutrition needs.Once participants are able to have a liquid diet they will receive nutrition shakes up to 3 times a day while in the hospital and for 4 weeks after discharge.
Participants will undergo tests to measure muscle mass, have blood draws, complete walking and strength tests, and surveys about quality of life. These tests will be done at several times throughout hospitalization and participants will be asked to return for a 3 month follow-up visit.
60 studies on the registry are indexed under Abdominal Injuries; 19 are open to participants now.
This study's planned enrollment of 150 is above the median of 125 across 30 interventional studies indexed under Abdominal Injuries.
Browse Abdominal Injuries studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
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Exclusion Criteria:
Total parenteral nutrition (TPN) will begin within 72 hours of abdominal surgery. Calorie needs will be determined by indirect calorimetry. Nutritional shakes will begin when a liquid diet is started. These will be taken 3 times a day while in the hospital and for 4 weeks after discharge.
Dietary Supplement: Nutrition Supplement
Standard nutrition as determined by clinical providers.
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.
Also known as: CLINIMIX E 8/14 sulfite-free, CLINOLIPID 20%, Nutritional shakes
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
Time frame: 3 months
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.
Time frame: baseline, day 14 or hospital discharge, 3 and 6 months post-hospital discharge
Change in muscle strength
This will be measured by comparing the changes in grip and quad strength tests between the two study arms.
Time frame: baseline, hospital discharge, 3 and 6 months post-hospital discharge
Change in muscle mass
This will be measured by comparing changes in bioelectrical impedance analysis (BIA) between the two study arms.
Time frame: baseline, hospital discharge, 3 and 6 months post-hospital discharge
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.
Time frame: baseline, 3 and 6 months post-hospital discharge
Change in cognition
This will be measured by looking at changes in mental health and cognition via questionnaires.
Time frame: baseline, 3 and 6 months post-hospital discharge
Infection
This will be measured by looking at the number of infections reported.
Time frame: hospital discharge, 3 and 6 months post-hospital discharge
Length of Hospital/ICU stay
This will be measured by recording the length of hospital stay noted in the medical record.
Time frame: hospital discharge
Mortality rate
This will be measured by survival after 6 months.
Time frame: 6 months post-hospital discharge
Change in muscle mitochondrial metabolism
This will be measured by doing urine and blood tests.
Time frame: admission, day 14, and hospital discharge
Change in key resilience and inflammation biomarkers
This will be measured utilizing the Duke Pepper Panel which serves as a comprehensive set of biological indicators typically incorporating: hormones, inflammatory markers and genomic factors.
Time frame: admission, day 14, and hospital discharge
Plan to share: No
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