Feeding the Patient at Nutritional Risk: Does the Clinical Outcome Improve?

Study Overview
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Brief Summary
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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.

Official Title
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Feeding the Patient at Nutritional Risk: Does the Clinical Outcome Improve?

Conditions
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Malnutrition

Intervention / Treatment
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* Other: Nutritional therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Normal hospital food | |
| Experimental: 2<br>Nutritional treatment | Other: Nutritional therapy<br>* Nutritional therapy by dietician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay |  | after stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Internal medicine patients