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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 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.

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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.

Conditions Studied

Critical Illness Trauma

Interventions

  • DIETARY_SUPPLEMENT Nutrition supplement - Ensure shakes

Study Locations (1)

North Carolina

  • Duke University Hospital - Durham

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2023-01-05
Est. Completion 2024-07-26
Phase NA

Sponsor

Duke University

1,725 total trials

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What the Registry Record Tells You About NCT05544162

The ClinicalTrials.gov registry entry for NCT05544162 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,138-participant average among 91 other Critical Illness trials with a reported enrollment target (99% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.