Nutritional Therapy for Delirium in Elderly Hospitalized Subjects
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in CAM-S (Confusion Assessment Method-Short) and 4 AT score from baseline to day 3 or up to day 4.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
- •Urinary tract infection
- •Clostridium-difficile infection
- •Other bone or tissue infection
- •Fever of unknown origin
排除标准
- •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
研究组 & 干预措施
Delirious subjects receiving active study product
Subjects will ingest an oral amino-acid containing nutritional supplement twice daily for up to 4 days.
干预措施: 260279 active study product (Dietary Supplement)
Control group
Delirious control group and non-delirious control group who receives standard treatment in the hospital.
结局指标
主要结局
Change in CAM-S (Confusion Assessment Method-Short) and 4 AT score from baseline to day 3 or up to day 4.
时间窗: 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).
次要结局
未报告次要终点