Personalized Nutrition to Improve Recovery in Trauma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nutrition Supplement.
- Who it may be relevant to
- Registry conditions: Abdominal Trauma. Basic parameters: from 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Personalized Targeted Nutrition Via StructurEd Nutrition Delivery Pathway to Improve Recovery of Physical Function in Trauma
Overview
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.
Interventions
- Dietary supplement Nutrition 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.
Primary outcome measures
- Change in six-minute walk distance (6 MWD) [Time frame: 3 months]
Secondary outcome measures (10)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Duke University Hospital — Durham
Identifiers
NCT: NCT06065202 · Pro00112343