Personalized Nutrition to Improve Recovery in Trauma (SeND Home)

Duke University

Status and phase: Enrolling; Phase 2

Conditions: Abdominal Trauma

Treatments: Dietary Supplement: Nutrition Supplement

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; Industry

Identifiers

NCT06065202

Pro00112343

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

SeND Home Pathway

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Nutrition Supplement

Standard Nutrition

No Intervention group

Description:

Standard nutrition as determined by clinical providers.