NCT01477723
Terminated
Phase 3
Evaluation of an Oral Nutritional Supplement Containing AN 777 in Older Hospitalized Patients
ConditionsPneumonia
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Pneumonia
- Sponsor
- Abbott Nutrition
- Enrollment
- 17
- Locations
- 14
- Primary Endpoint
- Leg Lean Mass
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
Brief Summary
Study objectives are to verify the loss of lean mass during a hospital stay in a group of older patients; to evaluate the effects of consuming a high-calorie complete and balanced oral nutritional supplement; to collect post-discharge information.
Investigators
Eligibility Criteria
Inclusion Criteria
- •≥ 55 years of age.
- •Admitted to hospital with a disease of respiratory system including acute respiratory diseases (e.g., pneumonia, acute bronchitis) or exacerbation of existing respiratory diseases.
- •Anticipated length of hospital stay of at least 3 days.
- •Ability to climb a flight of 10 stairs or walk a city block without the help of another person prior to hospitalization.
- •Able to consume foods and beverages orally.
Exclusion Criteria
- •Unstable heart failure which requires ICU admission.
- •Severe respiratory disease requiring long-term, continuous oxygen therapy.
- •Impaired renal function.
- •Impaired liver function.
- •Hospitalized for two or more days in past 4 weeks.
- •Requires intubation or tube feeding.
- •Expected to be transferred to an advanced care unit.
- •Body mass index of ≥ 40 kg/m
- •Active tuberculosis.
- •Ascites or severe edema.
Outcomes
Primary Outcomes
Leg Lean Mass
Time Frame: baseline to day 30
Secondary Outcomes
- Body Weight(baseline to day 30)
- Body Mass Index(baseline to day 30)
- Activities of daily living(baseline to day 30)
Study Sites (14)
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