Abdominal TraumaPhase 2SeND HomeNCT06065202
Personalized Nutrition to Improve Recovery in Trauma
A Phase 2 study testing Nutrition Supplement in people with Abdominal Trauma, run by Duke University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Abdominal Trauma
- What is being tested?
- Nutrition Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2024to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Hospital
Durham, North Carolina, 27710
Shauna Howell, 919-668-3771, shauna.eggertson@duke.edu
Krista Haines, MD
About this study
Official title: Personalized Targeted Nutrition Via StructurEd Nutrition Delivery Pathway to Improve Recovery of Physical Function 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.
Read the detailed 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.
- Conditions
- Abdominal Trauma
- Being tested
- Nutrition Supplement
- Keywords
- precision nutrition, critical care, trauma, parenteral nutrition, indirect calorimetry
- Medical subject headings
- Abdominal Injuries, Wounds and Injuries, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition SupplementDietary supplement
Also called CLINIMIX E 8/14 sulfite-free, CLINOLIPID 20%, Nutritional shakes
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.
| Study group | Role | What they receive |
|---|---|---|
| SeND Home Pathway | Experimental | 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. Receives: Dietary Supplement: Nutrition Supplement |
| Standard Nutrition | No intervention | Standard nutrition as determined by clinical providers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, 3 and 6 months post-hospital discharge
Infection
This will be measured by looking at the number of infections reported.
Measured: 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.
Measured: hospital discharge
Mortality rate
This will be measured by survival after 6 months.
Measured: 6 months post-hospital discharge
Change in muscle mitochondrial metabolism
This will be measured by doing urine and blood tests.
Measured: 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.
Measured: admission, day 14, and hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start12 Apr 2024
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal TraumaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Paul Wischmeyer, MD, Principal investigator, Duke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065202
- Sponsor's protocol ID
- Pro00112343
- Acronym
- SeND Home
- Status last verified
- Nov 2025
- First submitted
- 27 Sep 2023
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Targeted Nutrition Via StructurEd Nutrition Delivery Pathway to Improve Recovery of Physical Function in Trauma
- ClinicalTrials.gov ID
- NCT06065202
- Acronym / sponsor ID
- SeND Home / Pro00112343
- Conditions
- Abdominal Trauma
- Keywords
- precision nutrition, critical care, trauma, parenteral nutrition, indirect calorimetry
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense, Baxter Healthcare Corporation
- Study start
- 12 Apr 2024 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SeND Home Pathway | Experimental | Dietary Supplement: Nutrition SupplementTotal 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. |
| Standard Nutrition | No intervention | –Standard nutrition as determined by clinical providers. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition SupplementAlso: CLINIMIX E 8/14 sulfite-free, CLINOLIPID 20%, Nutritional shakesTotal 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. | Dietary supplement | SeND Home Pathway |
Primary outcome
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
10 secondary outcomes
Change in physical function
Time frame: baseline, day 14 or hospital discharge, 3 and 6 months post-hospital discharge
Change in muscle strength
Time frame: baseline, hospital discharge, 3 and 6 months post-hospital discharge
Change in muscle mass
Time frame: baseline, hospital discharge, 3 and 6 months post-hospital discharge
Change in Quality of Life (QoL)
Time frame: baseline, 3 and 6 months post-hospital discharge
Change in cognition
Time frame: baseline, 3 and 6 months post-hospital discharge
Infection
Time frame: hospital discharge, 3 and 6 months post-hospital discharge
Length of Hospital/ICU stay
Time frame: hospital discharge
Mortality rate
Time frame: 6 months post-hospital discharge
Change in muscle mitochondrial metabolism
Time frame: admission, day 14, and hospital discharge
Change in key resilience and inflammation biomarkers
Time frame: admission, day 14, and hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Wischmeyer, MD principal investigator
Duke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nutrition Supplement in people with Abdominal Trauma, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Krista Haines, MD (919-681-3784, krista.haines@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in six-minute walk distance (6 MWD) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.