Clinical trial NCT05066503: Nutritional Therapy for Delirium in Elderly Hospitalized Subjects
Official title: Nutritional Therapy for Delirium in Elderly Hospitalized Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Subacute Delirium
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 45
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in CAM-S (Confusion Assessment Method-Short) score from baseline to day 3 or up to day 4.
timeFrame: As determined over an up to 4-day intervention duration.
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: UAMS Center on Aging
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Gohar Azhar, M.D.
role: PRINCIPAL_INVESTIGATOR
References: