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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Nutrition Supplement

    Dietary 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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: SeND Home PathwayExperimental treatment 1 intervention
Group B: Standard NutritionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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Duke University

Lead sponsor

United States Department of Defense

Collaborator

Baxter Healthcare Corporation

Collaborator