Nutritional therapy to reduce delirium in hospitalized elderly patients
Nutritional Therapy for Delirium in Elderly Hospitalized Subjects
This study is testing whether a special amino acid blend can help prevent or lessen delirium in older adults who are hospitalized.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University of Arkansas Academic / other |
| Locations | 1 site (Little Rock, Arkansas) |
| Trial ID | NCT05066503 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effectiveness of a proprietary amino acid blend in preventing or reducing the severity of delirium in hospitalized older adults aged 60 and above. Up to 45 participants will be enrolled, including 30 delirious patients who will receive either the amino acid supplement or standard treatment, and 15 non-delirious control subjects who will not consume any study products. Participants will undergo multiple cognitive assessments and blood draws during their hospital stay to evaluate the impact of the intervention.
Who should consider this trial
Good fit: Ideal candidates are hospitalized individuals aged 60 and older with documented delirium or acute confusion due to specific infections.
Not a fit: Patients with chronic kidney disease, major psychiatric illnesses, or those whose delirium is caused by drug overdose or alcohol withdrawal may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management of delirium in elderly patients, enhancing their recovery and overall hospital experience.
How similar studies have performed: While similar nutritional interventions have been explored, this specific amino acid blend is a novel approach in the context of delirium management.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Little Rock, Arkansas
- UAMS Center on Aging — Little Rock, Arkansas, United States (Recruiting)
Study contacts
- Principal investigator: Gohar Azhar, M.D. — University of Arkansas
- Study coordinator: Gohar Azhar, M.D.
- Email: azhargohar@uams.edu
- Phone: 5015265935
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.