NCT00440453CompletedPhase 4
Feeding the Patient at Nutritional Risk: Does the Clinical Outcome Improve?
Insel Gruppe AG, University Hospital Bern1 site in 1 country200 target enrollmentStarted: February 1, 2007Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Length of stay
Study Overview
Brief Summary
The aim of the present study is to take stronger action in solving the problems of malnutrition in the hospital setting and in the first two months after patient's discharge. The main objective is to evaluate the clinical benefit (eg. QoL, body composition and body function) of nutritional intervention (nutritional therapy) in a sample of patients at nutritional risk according to the NRS 2002.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •all patients coming on station
Exclusion Criteria
- •patients with a screening total score <3 according to the NRS-2002 system
- •less than 18 years of age, expected hospital stay less than 4 days
- •expected survival less than 1 month
- •pregnant or lactating women
- •patients with psychiatric disorders
- •patients with cardiac failure as defined by the Goldmann classification class >II (recent rest pain, unstable angina pectoris)
- •patients with respiratory failure (Peak Flow Rate: PEFR <50%)
- •patients with hepatic dysfunction (Child >A)
- •patients suffering from an intestinal obstruction or ileus
- •patients with renal failure (creatinine >250 μmol/l) or receiving haemodialysis
- •patients that are already receiving, or are planned to receive parenteral nutrition
- •patients unable to understand the German language
Arms & Interventions
1
No Intervention
Normal hospital food
2
Experimental
Nutritional treatment
Intervention: Nutritional therapy (Other)
Outcomes
Primary Outcomes
Length of stay
Time Frame: after stay
Secondary Outcomes
- Quality of life(2 months after stay)
- Changes in body weight (measured day 1-2, 8, 28 and 56) and body composition (BMI, MAC, TSF) (measured day 1-2 and 8)(during stay)
- Changes in muscle function (handgrip dynamometry) (measured day 1-2 and 8)(during stay)
- Rate of accurately defined complications (infectious and non-infectious) (Table 2). Infectious are defined according to the US Centre of Disease Control [115].(during stay)
- Rate of accurately defined post-discharge complications (infectious and non-infectious) (Table 2)(after stay)
- Rate of re-hospitalization (within 8 weeks after randomisation)(after stay)
- Rate of mortality(during and after stay)
Investigators
Study Sites (1)
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