NCT01626742已完成3 期
A Randomized Double Blinded Controlled Trial of an Oral Nutritional Supplement Containing AN 777 in Older Hospitalized Patients
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 652
- 试验地点
- 236
- 主要终点
- Return to hospital or death
研究概览
简要总结
Evaluate effects of an oral nutritional supplement on healthcare outcomes in older hospitalized adults. Also referred to as the NOURISH Study - Nutrition effect On Unplanned Readmissions and Survival in Hospitalized patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 65 years of age.
- •Admitted to hospital with diagnosis of heart failure, acute myocardial infarction, pneumonia, or chronic obstructive pulmonary disease.
- •Subjective Global Assessment rating of B or C.
- •Length of hospital stay anticipated to be > 3 days and < 12 days
- •Able to consume foods and beverages orally.
- •Functionally ambulatory during the 30 days prior to admission.
排除标准
- •Uncontrolled hypertension
- •Diagnosis of diabetes
- •Current active cancer or recently treated cancer
- •Impaired renal function
- •Liver failure, acute Hepatitis, or hepatic encephalopathy
- •Active tuberculosis.
- •Disorder of gastrointestinal tract
- •Autoimmune disorder
- •Intubation, and/or tube or parenteral feeding.
- •Severe dementia or delirium, brain metastases, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures
- •Allergy or intolerance to any of the ingredients in the study products.
- •Body mass index of ≥ 40 kg/m
- •Resident in a nursing home or other residential facility.
- •Planned surgery during course of the study.
结局指标
主要结局
Return to hospital or death
时间窗: 90 days
次要结局
- Return to hospital or death(30 and 60 days)
- Hospital Days(90 days)
- Activities of Daily Living(90 days)
研究者
研究点 (236)
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