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

Insel Gruppe AG, University Hospital Bern1 site in 1 country200 target enrollmentFebruary 2007

ConditionsMalnutrition

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Malnutrition
Sponsor: Insel Gruppe AG, University Hospital Bern
Enrollment: 200
Locations: 1
Primary Endpoint: Length of stay
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

February 2007

End Date

August 2008

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Insel Gruppe AG, University Hospital Bern

Eligibility Criteria

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

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)