Subacute Delirium
Conditions
Brief summary
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 60 people will be enrolled.20 will be asked to drink this blend twice a day for up to 4 days, and 20 will receive standard treatment in the hospital for the same time period. The other 20 subjects will be non-delirious control subjects who do not consume any study products.
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 40 delirious and 20 non-delirious subjects (Aged 60 years and older) of any gender or ethnicity will be enrolled (60 subjects maximum). Twenty patients with delirium will be asked to drink this blend twice a day for up to 4 days, and 20 patients with delirium will receive standard treatment in the hospital for the same time period. The other 20 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.
Interventions
DIETARY_SUPPLEMENT260279 active study product
The active study product (20g per serving) contains 13.6g of amino acids and natural flavors, citric acid, malic acid, and stevia for flavoring.
Sponsors
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in CAM-S (Confusion Assessment Method-Short) and 4 AT score from baseline to day 3 or up to day 4. | As determined over an up to 4-day intervention duration. | CAM-S and 4 AT is a tool to determine and quantify delirium. Subjects in the non-control arms will undergo this test twice each day. The score ranges from 0-7, with lower numbers being better (little to no signs of delirium). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGohar Azhar, M.D.
University of Arkansas
Outcome results
None listed