Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06065202
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-09-27
Brief Title:
Personalized Nutrition to Improve Recovery in Trauma
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Personalized Targeted Nutrition Via StructurEd Nutrition Delivery Pathway to Improve Recovery of Physical Function in Trauma
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SeND Home
Brief 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
Detailed Description:
Severe abdominal trauma can impact patients in a variety of ways Current data shows that trauma patients can experience problems with physical function muscle weakness and poor quality of life after they are released from the hospital There is a critical need to improve nutrition in trauma patients with severe abdominal injuries to optimize the recovery process The purpose of this study is to evaluate if the use of a planned nutrition delivery plan with early intravenous IV nutrition will improve outcomes Participants will be randomly assigned 11 like flipping a coin to the SeND Home program or routine care
Participants in the standard of care program will receive standard nutrition delivery as determined by clinical care providers This may include TPN
Participants in the SeND Home program will receive TPN within 72 hours of abdominal surgery Indirect calorimetry will be used to determine nutrition needsOnce participants are able to have a liquid diet they will receive nutrition shakes up to 3 times a day while in the hospital and for 4 weeks after discharge
Participants will undergo tests to measure muscle mass have blood draws complete walking and strength tests and surveys about quality of life These tests will be done at several times throughout hospitalization and participants will be asked to return for a 3 month follow-up visit
Participants in the standard of care program will receive standard nutrition delivery as determined by clinical care providers This may include TPN
Participants in the SeND Home program will receive TPN within 72 hours of abdominal surgery Indirect calorimetry will be used to determine nutrition needsOnce participants are able to have a liquid diet they will receive nutrition shakes up to 3 times a day while in the hospital and for 4 weeks after discharge
Participants will undergo tests to measure muscle mass have blood draws complete walking and strength tests and surveys about quality of life These tests will be done at several times throughout hospitalization and participants will be asked to return for a 3 month follow-up visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None