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NCT Number: NCT06065202

Personalized Nutrition to Improve Recovery in Trauma

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.

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Key information

Conditions

Abdominal Trauma Abdominal Injuries Hyperphagia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Wounds and Injuries

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Duke University Hospital

Durham, North Carolina, 27710, United States

Location status: Recruiting

Location contact

Krista Haines, MD

SUB_INVESTIGATOR

Shauna Howell

CONTACT

[email protected]

919-668-3771

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: CLINIMIX E 8/14 sulfite-free, CLINOLIPID 20%, Nutritional shakes

Primary outcomes

  1. Change in six-minute walk distance (6 MWD)

    Time frame: 3 months

    Change in 6MWD from baseline to day 14 or hospital discharge will be compared between the two study arms

Secondary outcomes

  1. Change in physical function

    Time frame: baseline, day 14 or hospital discharge, 3 and 6 months post-hospital discharge

    This will be measured by comparing the changes in physical function tests (4 meter walk, sit-to-stand) between the two study arms.

  2. Change in muscle strength

    Time frame: baseline, hospital discharge, 3 and 6 months post-hospital discharge

    This will be measured by comparing the changes in grip and quad strength tests between the two study arms.

  3. Change in muscle mass

    Time frame: baseline, hospital discharge, 3 and 6 months post-hospital discharge

    This will be measured by comparing changes in bioelectrical impedance analysis (BIA) between the two study arms.

  4. Change in Quality of Life (QoL)

    Time frame: baseline, 3 and 6 months post-hospital discharge

    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.

  5. Change in cognition

    Time frame: baseline, 3 and 6 months post-hospital discharge

    This will be measured by looking at changes in mental health and cognition via questionnaires.

  6. Infection

    Time frame: hospital discharge, 3 and 6 months post-hospital discharge

    This will be measured by looking at the number of infections reported.

  7. Length of Hospital/ICU stay

    Time frame: hospital discharge

    This will be measured by recording the length of hospital stay noted in the medical record.

  8. Mortality rate

    Time frame: 6 months post-hospital discharge

    This will be measured by survival after 6 months.

  9. Change in muscle mitochondrial metabolism

    Time frame: admission, day 14, and hospital discharge

    This will be measured by doing urine and blood tests.

  10. Change in key resilience and inflammation biomarkers

    Time frame: admission, day 14, and hospital discharge

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hilary Winthrop

CONTACT

[email protected]

919-668-7238

Krista Haines, MD

CONTACT

[email protected]

919-681-3784

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Baxter Healthcare Corporation
  • United States Department of Defense

Registry information

Official study title

Personalized Targeted Nutrition Via StructurEd Nutrition Delivery Pathway to Improve Recovery of Physical Function in Trauma

Acronym: SeND Home

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 3, 2023
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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