RECRUITING

Personalized Nutrition to Improve Recovery in Trauma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-12
Study Completion:2025-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06065202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18+ years old
  2. * Penetrating abdominal trauma requiring emergent major abdominal surgery
  3. * Admitted to the surgical ICU
  4. * Not expected to receive oral nutrition for 72 hours or more
  1. * Patients who are unable to ambulate at baseline
  2. * Expected withdrawal of life-sustaining treatment within 48 hours
  3. * Prisoners
  4. * Positive pregnancy test for women of child bearing potential.

Contacts and Locations

Study Contact

Krista Haines, MD
CONTACT
919-681-3784
krista.haines@duke.edu
Shauna Howell
CONTACT
919-613-1588
shauna.eggertson@duke.edu

Principal Investigator

Paul Wischmeyer, MD
PRINCIPAL_INVESTIGATOR
Duke

Study Locations (Sites)

Duke University Hospital
Durham, North Carolina, 27710
United States

Collaborators and Investigators

Sponsor: Duke University

  • Paul Wischmeyer, MD, PRINCIPAL_INVESTIGATOR, Duke

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-12
Study Completion Date2025-09-30

Study Record Updates

Study Start Date2024-04-12
Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

  • precision nutrition
  • critical care
  • trauma
  • parenteral nutrition
  • indirect calorimetry

Additional Relevant MeSH Terms

  • Abdominal Trauma