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NCT06065202 · ClinicalTrials.gov registry record · Phase 2
Personalized Nutrition to Improve Recovery in Trauma
A Phase 2 study of Abdominal Trauma, sponsored by Duke University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT06065202 is a Phase 2 study of Abdominal Trauma that is actively recruiting participants, run by Duke University. The registered enrollment target is 150 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06065202, a Phase 2 study of Abdominal Trauma, is actively recruiting participants, sponsored by Duke University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Nutrition Supplement
Study Locations (1)
North Carolina
- Duke University Hospital - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-04-12 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06065202
The ClinicalTrials.gov registry entry for NCT06065202 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Abdominal Trauma appearing as the primary indexed condition, and to 1 intervention - of which Nutrition Supplement is the first listed.
NCT06065202 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT06065202 about?
NCT06065202 is a clinical study titled "Personalized Nutrition to Improve Recovery in Trauma". 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 nutritio...
What is the current status of trial NCT06065202?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2024-04-12. Estimated completion is 2026-06-30.
What conditions does trial NCT06065202 study?
This clinical trial studies the following conditions: Abdominal Trauma.
What interventions are being tested in trial NCT06065202?
The interventions under investigation include: Nutrition Supplement (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06065202?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06065202 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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