Personalized Nutrition Delivery to Improve Resilience in Older Adult Trauma Patients

NCT05544162 | Completed Results DMC

• 1 other identifier: Pro00110867
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Pilot study designed to set up for an randomized clinical trial (RCT) comparing the SeND Home pathway to a standard of care nutrition delivery in critically ill older adult trauma patients. Subjects will be randomized 3:1 to either SeND Home precision nutrition pathway or control arm. Subjects randomized to the SeND Home arm will receive oral nutrition supplements (ONS) up to 3 times per day while in the hospital and for 4 weeks after discharge. Subjects in the standard of care arm will receive normal nutrition recommendations from their clinical providers. Participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass.

Conditions

Trauma; Critical Illness

Outcome Measures

Primary Outcomes (1)

• Number of Patients Recruited

  This outcome is a measure of feasibility of the SeND Home pathway

  Baseline

Secondary Outcomes (9)

• Number of Study Participants Who Adhere to the SeND Home Treatment Protocol

  approximately 98 days

• Percentage of Participants Retained to Study Completion

  hospital stay plus 90 days

• Time to Complete Each Outcome

  3 months

• How Well Outcome Assessments Are Tolerated

  3 months

• Duration of Testing Time

  3 months

Study Arms (2)

SeND Home precision nutrition pathway

EXPERIMENTAL

Oral nutrition supplements (ONS) will be given, at maximum, three times per day throughout hospitalization. Upon discharge, participants will be given 4-weeks' worth of oral supplements to take. Adjustments may be made based on indirect calorimetry (IC) measurements by the clinical dietitian.

Dietary Supplement: Nutrition supplement - Ensure shakes

Control pathway

NO INTERVENTION

Standard of care nutrition delivery throughout hospitalization. Upon discharge they will be sent home with standard nutrition information without Indirect Calorimetry (IC) guidance.

Interventions

Nutrition supplement - Ensure shakes DIETARY_SUPPLEMENT

Ensure shakes will be take up to 3 times a day throughout hospitalization and for 4 weeks after discharge.

SeND Home precision nutrition pathway

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are at least 60 years old and admitted to the trauma service
• Patients who have had a standard of care CT scan

You may not qualify if:

• Expected withdrawal of life-sustaining treatment within 48 hours
• Prisoners
• Unable to provide informed consent
• Non-English speakers
• Traumatic Brain Injury
• Allergic to milk or soy ingredients (Common allergen in Ensure shakes).
• Pregnancy

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Haines KL, Walsh J, Sytsma T, Tiko-Okoye C, Molinger J, Howell S, Agarwal S, Vatsaas C, Cox CE, Schmader K, Wischmeyer PE. Predictive Energy Equations Inaccurately Estimate Metabolic Demands of Older Adult Trauma Patients. J Surg Res. 2024 Oct;302:525-532. doi: 10.1016/j.jss.2024.07.098. Epub 2024 Aug 22.

  PMID: 39178568 DERIVED

MeSH Terms

Conditions

Wounds and Injuries; Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Krista Haines
• Organization: Duke University Medical Center

krista.haines@duke.edu

(919) 684-8111

Study Officials

• Krista Haines, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 16, 2022
• Study Start: January 5, 2023
• Primary Completion: February 1, 2024
• Study Completion: July 26, 2024
• Last Updated: June 2, 2026
• Results First Posted: June 2, 2026

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)