NCT01626742
Completed
Phase 3
A Randomized Double Blinded Controlled Trial of an Oral Nutritional Supplement Containing AN 777 in Older Hospitalized Patients
ConditionsHospitalized Elderly
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Hospitalized Elderly
- Sponsor
- Abbott Nutrition
- Enrollment
- 652
- Locations
- 118
- Primary Endpoint
- Return to hospital or death
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Return to hospital or death
Time Frame: 90 days
Secondary Outcomes
- Return to hospital or death(30 and 60 days)
- Hospital Days(90 days)
- Activities of Daily Living(90 days)
Study Sites (118)
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