Nutritional Therapy for Delirium in Elderly Hospitalized Subjects
Purpose
The investigators have developed a proprietary blend of amino acids that they think will help to prevent or reduce the severity of delirium in older adults (60 years and older) who are hospitalized for certain infections. In this study, up to 45 people will be enrolled.15 will be asked to drink this blend twice a day for up to 4 days, and 15 will receive standard treatment in the hospital for the same time period. The other 15 subjects will be non-delirious control subjects who do not consume any study products.
Condition
- Subacute Delirium
Eligibility
- Eligible Ages
- Over 60 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
Delirious cohort 1. Aged 60 years and older. 2. Documented presence of either delirium, acute confusion, or altered mental status in medical record. 3. Currently hospitalized with a diagnosis of one of the following: 1. sepsis/septicemia 2. Pneumonia 3. Urinary tract infection 4. Clostridium-difficile infection 5. Other bone or tissue infection 6. Fever of unknown origin Inclusion Criteria: NON-Delirious cohort 1. Aged 60 years and older. 2. Current diagnosis of one of the following: 1. sepsis/septicemia 2. Pneumonia 3. Urinary tract infection 4. Clostridium-difficile infection 5. Other bone or tissue infection 6. Fever of unknown origin
Exclusion Criteria
all subjects 1. Chronic kidney disease (eGFR <30). 2. Admitted to the hospital for major psychiatric illness. 3. Major psychiatric illness not controlled by medication/treatment. 4. Delirium etiology of drug overdose or alcohol withdrawal. 5. Major surgery within the past five days. 6. Known or suspected Covid-19 positive. 7. Continuous feeding tube
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Delirious subjects receiving active study product |
Subjects will ingest an oral amino-acid containing nutritional supplement twice daily for up to 4 days. |
|
|
No Intervention Control group |
Delirious control group and non-delirious control group who receives standard treatment in the hospital. |
|
Recruiting Locations
Little Rock, Arkansas 72205
More Details
- NCT ID
- NCT05066503
- Status
- Recruiting
- Sponsor
- University of Arkansas
Detailed Description
This will be an interventional pilot study to determine the effectiveness of a specific amino acid supplement developed by the investigators versus standard treatment in mitigating delirium in geriatric patients hospitalized at UAMS for certain infections. Up to 30 delirious and 15 non-delirious subjects (Aged 60 years and older) of any gender or ethnicity will be enrolled (45 subjects maximum). Fifteen patients with delirium will be asked to drink this blend twice a day for up to 4 days, and 15 patients with delirium will receive standard treatment in the hospital for the same time period. The other 15 subjects will be non-delirious control subjects who do not consume any study products. All subjects will undergo 2-5 blood draws and 3-7 cognitive assessments while they are admitted to the hospital, depending on study group assignment and discharge date.