Ignite Creation Date:
2024-10-25 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521086
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-03
Brief Title:
Optimizing Recovery in Trauma Patients by Integrating Enhanced Nutrition Delivery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimizing Recovery in Trauma Patients Integrating Enhanced Nutrition Delivery With Muscle Assessments Functional Outcomes and Quality of Life
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective randomized controlled trial designed to evaluate the impact of enhanced protein supplementation compared to a standard of care nutrition delivery in critically ill older adult trauma patients Subjects will be randomized 11 to either enhanced nutrition or control arm Subjects randomized to the enhanced nutrition 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
Detailed Description:
This is a prospective randomized controlled trial designed to evaluate the impact of enhanced protein supplementation compared to a standard of care nutrition delivery in critically ill older adult trauma patients Enhanced protein supplementation supports patients from ICU admission to 4-weeks post-hospital discharge providing a comprehensive and personalized plan of care carried to completion
Subjects will be randomized 11 to enhanced nutrition or control arm Subjects randomized enhanced nutrition oral nutrition supplements Fresenius KCAL shakes 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 They will also be asked to complete walking and strength tests and surveys about quality of lifeThese will be done at hospital admission day 14 or hospital discharge and at a one month post-discharge follow-up visit
Subjects will be randomized 11 to enhanced nutrition or control arm Subjects randomized enhanced nutrition oral nutrition supplements Fresenius KCAL shakes 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 They will also be asked to complete walking and strength tests and surveys about quality of lifeThese will be done at hospital admission day 14 or hospital discharge and at a one month post-discharge follow-up visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None