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NCT05544162 · ClinicalTrials.gov registry record · NA
Personalized Nutrition Delivery to Improve Resilience in Older Adult Trauma Patients
A NA study of Critical Illness and Trauma, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05544162: Completed NA study of Critical Illness and Trauma, sponsored by Duke University.
NCT05544162 is a NA study of Critical Illness and Trauma that has completed, run by Duke University. The registered enrollment target is 40 participants, below the 3,138-participant average among 91 other Critical Illness trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05544162, a NA study of Critical Illness and Trauma, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
This outcome is a measure of feasibility of the SeND Home pathway
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Nutrition supplement - Ensure shakes
Study Locations (1)
North Carolina
- Duke University Hospital - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-01-05 |
| Est. Completion | 2024-07-26 |
| Phase | NA |
What the finished NCT05544162 record still lists
NCT05544162 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 3,138-participant average among 91 other Critical Illness trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Critical Illness appearing as the primary indexed condition, and to 1 intervention - of which Nutrition supplement - Ensure shakes is the first listed.
NCT05544162 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05544162 about?
NCT05544162 is a clinical study titled "Personalized Nutrition Delivery to Improve Resilience in Older Adult Trauma Patients". 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. Subj...
What is the current status of trial NCT05544162?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2023-01-05. Estimated completion is 2024-07-26.
What conditions does trial NCT05544162 study?
This clinical trial studies the following conditions: Critical Illness, Trauma.
What interventions are being tested in trial NCT05544162?
The interventions under investigation include: Nutrition supplement - Ensure shakes (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05544162?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05544162 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05544162's enrollment target sits among peer trials
40 80th of 91 higher than 10 of 91 other Critical Illness trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Critical Illness trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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