Clinical trial NCT06065202: Personalized Nutrition to Improve Recovery in Trauma
Official title: Personalized Targeted Nutrition Via StructurEd Nutrition Delivery Pathway to Improve Recovery of Physical Function in Trauma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Abdominal Trauma
Keywords: precision nutrition
critical care
trauma
parenteral nutrition
indirect calorimetry
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Baxter Healthcare Corporation
First posted: 2023-10-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* 18+ 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.

Primary outcomes:
measure: Change in six-minute walk distance (6 MWD)
timeFrame: 3 months
Secondary outcomes:
measure: Change in physical function
timeFrame: baseline, day 14 or hospital discharge, 3 and 6 months post-hospital discharge
measure: Change in muscle strength
timeFrame: baseline, hospital discharge, 3 and 6 months post-hospital discharge
measure: Change in muscle mass
timeFrame: baseline, hospital discharge, 3 and 6 months post-hospital discharge
measure: Change in Quality of Life (QoL)
timeFrame: baseline, 3 and 6 months post-hospital discharge
measure: Change in cognition
timeFrame: baseline, 3 and 6 months post-hospital discharge
measure: Infection
timeFrame: hospital discharge, 3 and 6 months post-hospital discharge
measure: Length of Hospital/ICU stay
timeFrame: hospital discharge
measure: Mortality rate
timeFrame: 6 months post-hospital discharge
measure: Change in muscle mitochondrial metabolism
timeFrame: admission, day 14, and hospital discharge
measure: Change in key resilience and inflammation biomarkers
timeFrame: admission, day 14, and hospital discharge
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
affiliation: Duke
name: Paul Wischmeyer, MD
role: PRINCIPAL_INVESTIGATOR
References: