Nutritional Therapy for Delirium in Elderly Hospitalized Subjects
Primary Purpose
Subacute Delirium
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
260279 active study product
260279 placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Subacute Delirium
Eligibility Criteria
Inclusion Criteria: Delirious cohort
- Aged 65 years and older.
- Documented presence of either delirium, acute confusion, or altered mental status in medical record.
Currently hospitalized with a diagnosis of one of the following:
- sepsis/septicemia
- Pneumonia
- Urinary tract infection
- Clostridium-difficile infection
Inclusion Criteria: NON-Delirious cohort
- Aged 65 years and older.
Current diagnosis of one of the following:
- sepsis/septicemia
- Pneumonia
- Urinary tract infection
- Clostridium-difficile infection
Exclusion Criteria: all subjects
- Chronic kidney disease (eGFR <30).
- History of Parkinson's disease.
- History of a major psychiatric illness.
- Delirium etiology of drug overdose or alcohol withdrawal.
- Current hyponatremia.
- Currently on sedative/hypnotic medications and not expected to stop.
- Major surgery within the past two weeks.
- Known or suspected Covid-19 positive.
Sites / Locations
- UAMS Center on AgingRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
No Intervention
Arm Label
Delirious subjects receiving active study product
Delirious subjects receiving placebo
Non-delirious control subjects who receive no intervention
Arm Description
Subjects will ingest an oral amino-acid containing nutritional supplement twice daily for up to 4 days.
Subjects will ingest a flavored, sweetened, inactive drink twice daily for up to 4 days.
Subjects receive no intervention and are observed for 2-3 days.
Outcomes
Primary Outcome Measures
Change in CAM-S (Confusion Assessment Method-Short) score from baseline to day 3 or up to day 4.
CAM-S 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).
Secondary Outcome Measures
Full Information
NCT ID
NCT05066503
First Posted
September 23, 2021
Last Updated
September 18, 2023
Sponsor
University of Arkansas
1. Study Identification
Unique Protocol Identification Number
NCT05066503
Brief Title
Nutritional Therapy for Delirium in Elderly Hospitalized Subjects
Official Title
Nutritional Therapy for Delirium in Elderly Hospitalized Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2020 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 people 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 drink a placebo (sugar water) 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 a controlled, randomized 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 at hospitalized UAMS for certain infections. Up to 30 delirious and 15 non-delirious subjects of any gender or ethnicity will be enrolled (45 subjects maximum). 15 will be asked to drink this blend twice a day for up to 4 days, and 15 will drink a placebo (sugar water) 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacute Delirium
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Delirious subjects receiving active study product
Arm Type
Active Comparator
Arm Description
Subjects will ingest an oral amino-acid containing nutritional supplement twice daily for up to 4 days.
Arm Title
Delirious subjects receiving placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will ingest a flavored, sweetened, inactive drink twice daily for up to 4 days.
Arm Title
Non-delirious control subjects who receive no intervention
Arm Type
No Intervention
Arm Description
Subjects receive no intervention and are observed for 2-3 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
260279 active study product
Other Intervention Name(s)
there is not a non-proprietary name for this supplement.
Intervention Description
The active study product (20g per serving) contains 13.6g of amino acids and natural flavors, citric acid, malic acid, and stevia for flavoring.
Intervention Type
Dietary Supplement
Intervention Name(s)
260279 placebo
Intervention Description
A drink made of flavored, sweetened water.
Primary Outcome Measure Information:
Title
Change in CAM-S (Confusion Assessment Method-Short) score from baseline to day 3 or up to day 4.
Description
CAM-S 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).
Time Frame
As determined over an up to 4-day intervention duration.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Delirious cohort
Aged 60 years and older.
Documented presence of either delirium, acute confusion, or altered mental status in medical record.
Currently hospitalized with a diagnosis of one of the following:
sepsis/septicemia
Pneumonia
Urinary tract infection
Clostridium-difficile infection
Other bone or tissue infection
Fever of unknown origin
Inclusion Criteria: NON-Delirious cohort
Aged 60 years and older.
Current diagnosis of one of the following:
sepsis/septicemia
Pneumonia
Urinary tract infection
Clostridium-difficile infection
Other bone or tissue infection
Fever of unknown origin
Exclusion Criteria: all subjects
Chronic kidney disease (eGFR <30).
Admitted to the hospital for major psychiatric illness.
Major psychiatric illness not controlled by medication/treatment.
Delirium etiology of drug overdose or alcohol withdrawal.
Major surgery within the past five days.
Known or suspected Covid-19 positive.
Continuous feeding tube
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gohar Azhar, M.D.
Phone
5015265935
Email
azhargohar@uams.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gohar Azhar, M.D.
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAMS Center on Aging
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reino Henderson, PA
Phone
501-603-1514
Email
RAHenderson@uams.edu
First Name & Middle Initial & Last Name & Degree
Jeanne Wei, M.D.
First Name & Middle Initial & Last Name & Degree
Regina Gibson, Ph.D.
First Name & Middle Initial & Last Name & Degree
Karen Coker, Ph.D.
First Name & Middle Initial & Last Name & Degree
Pankaj Patyal, Ph.D.
First Name & Middle Initial & Last Name & Degree
Robert Wolfe, Ph.D.
First Name & Middle Initial & Last Name & Degree
Gohar Azhar, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Nutritional Therapy for Delirium in Elderly Hospitalized Subjects
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