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Amino Acid Blend
Amino Acid Blend for Delirium
N/A
Recruiting
Led By Gohar Azhar, M.D.
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 sepsis/septicemia, pneumonia, urinary tract infection, Clostridium-difficile infection, other bone or tissue infection, or fever of unknown origin
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up as determined over an up to 4-day intervention duration.
Awards & highlights
Study Summary
This trialwill test if a blend of amino acids can help prevent delirium in older people in hospital with infections. 45 people will drink either the blend or a placebo.
Who is the study for?
This trial is for hospitalized individuals aged 60 or older with delirium due to infections like sepsis, pneumonia, UTI, bone/tissue infection, or fever of unknown origin. It excludes those with chronic kidney disease, recent major surgery, uncontrolled psychiatric illness, suspected COVID-19, and delirium from substance withdrawal.Check my eligibility
What is being tested?
The study tests a special amino acid blend thought to prevent or lessen delirium severity against a placebo (sugar water). Of the up to 45 participants enrolled: 15 will take the blend twice daily for four days; another 15 will have the placebo; and the remaining are non-delirious controls not consuming any product.See study design
What are the potential side effects?
Potential side effects aren't specified but may include reactions typical of nutritional supplements such as gastrointestinal discomfort. Since it's an amino acid blend designed for elderly patients, risks are likely minimal compared to pharmaceutical drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 60 or older, currently hospitalized with an infection or fever, and have experienced confusion or altered mental status.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ as determined over an up to 4-day intervention duration.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~as determined over an up to 4-day intervention duration.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in CAM-S (Confusion Assessment Method-Short) score from baseline to day 3 or up to day 4.
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: Non-delirious control subjects who receive no interventionActive Control1 Intervention
Subjects receive no intervention and are observed for 2-3 days.
Group II: Delirious subjects receiving active study productActive Control1 Intervention
Subjects will ingest an oral amino-acid containing nutritional supplement twice daily for up to 4 days.
Group III: Delirious subjects receiving placeboPlacebo Group1 Intervention
Subjects will ingest a flavored, sweetened, inactive drink twice daily for up to 4 days.
Find a Location
Who is running the clinical trial?
University of ArkansasLead Sponsor
486 Previous Clinical Trials
150,238 Total Patients Enrolled
Gohar Azhar, M.D.Principal InvestigatorUniversity of Arkansas
1 Previous Clinical Trials
21 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 60 or older with a current diagnosis of a serious infection.I am 60 or older, currently hospitalized with an infection or fever, and have experienced confusion or altered mental status.My kidney function is severely reduced.I have been hospitalized for a serious mental health issue.My mental health condition is well-managed with medication or treatment.I have or might have COVID-19.I have not had major surgery in the last 5 days.I use a feeding tube all the time.You are experiencing confusion or disorientation due to taking too much medication or stopping alcohol suddenly.
Research Study Groups:
This trial has the following groups:- Group 1: Delirious subjects receiving placebo
- Group 2: Non-delirious control subjects who receive no intervention
- Group 3: Delirious subjects receiving active study product
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many test subjects are participating in this research project?
"Affirmative, according to clinicaltrials.gov this active trial is searching for suitable individuals. It was posted on November 16th 2020 and has been recently updated on 1st November 2022. 45 participants are required from one site in particular."
Answered by AI
Is this study actively searching for participants?
"Affirmative, the information posted on clinicaltrials.gov confirms that this medical study is still in search of participants. Initially published on November 16th 2020 and most recently edited on November 1st 2022, the research seeks to recruit 45 patients from a single site."
Answered by AI
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