Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 1:1 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.
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 1:1 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 life.These will be done at hospital admission, day 14 or hospital discharge, and at a one month post-discharge follow-up visit.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Protein Supplementation | Experimental | Oral nutrition supplements (ONS) will be given, at maximum, three times per day throughout hospitalization. Upon discharge, participants will be given 4-weeks' worth of oral supplements to take. Adjustments may be made based on indirect calorimetry (IC) measurements. |
|
| Control Pathway | No Intervention | Standard of care nutrition delivery throughout hospitalization. Upon discharge participants will be sent home with standard nutrition information without Indirect Calorimetry (IC) guidance. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrition Supplements - Fresubin KCAL Drinks | Dietary Supplement | Fresubin drinks will be taken up to 3 times a day throughout hospitalization and for 4 weeks after discharge. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in muscle mass as a measure of muscle quality | Baseline to one month post-discharge (approximately six weeks) | |
| Change in glycogen stores as a measure of muscle quality | Baseline to one month post-discharge (approximately six weeks) | |
| Change in body composition (percentage of a body's weight that is fat tissue) as a measure of muscle quality | Body composition is the percentage of a body's weight that is fat tissue. | Baseline to one month post-discharge (approximately six weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in six minute walk test (6MWT) distance | The 6MWT assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance. | Baseline to one month post-discharge (approximately six weeks) |
| Change in four meter gait speed |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul Wischmeyer, MD | Contact | 919-681-9660 | paul.wischmeyer@duke.edu | |
| Krista Haines, MD | Contact | 919-681-3784 | krista.haines@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Paul Wischmeyer, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Hospital | Recruiting | Durham | North Carolina | 27710 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Four meter gait speed is the time one takes to walk four meters on a level surface.
| Baseline to one month post-discharge (approximately six weeks) |
| Change in 30-second sit to stand test | This test measures the number of times an individual can stand from a chair with no assistance in 30 seconds. This test is used to assess functional lower body strength. | Baseline to one month post-discharge (approximately six weeks) |
| Change in grip strength | Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It can be used as a screening tool for the measurement of upper body strength and overall strength. | Baseline to one month post-discharge (approximately six weeks) |
| Change in quadriceps strength | ED (electromechanical dynamometry) can be used in either isometric or isokinetic mode. Quadriceps strength is expressed as peak knee extensor torque, which is produced at around 60° knee flexion. | Baseline to one month post-discharge (approximately six weeks) |