Nutritional Therapy for Delirium in Elderly Hospitalized Subjects

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка 260279 active study product
  The active study product (20g per serving) contains 13.6g of amino acids and natural flavors, citric acid, malic acid, and stevia for flavoring.

Первичные конечные точки

• Change in CAM-S (Confusion Assessment Method-Short) and 4 AT score from baseline to day 3 or up to day 4. [Срок оценки: As determined over an up to 4-day intervention duration.]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• UAMS Center on Aging — Little Rock

Идентификаторы

NCT: NCT05066503 · 260279

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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