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

Phase 4

Completed

• Conditions: Malnutrition
• Interventions: Other: Nutritional therapy

• Registration Number: NCT00440453
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-02-23
• Study First Submitted QC: 2007-02-23
• Study First Posted: 2007-02-27
• Primary Completion: 2008-06
• Study Completion: 2008-08
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-22
• Last Update Posted: 2011-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	Nutritional therapy	Nutritional treatment

Primary Outcome Measures

Name	Time	Method
Length of stay	after stay

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University hospital; 🇨🇭 Bern, BE, Switzerland