Feeding the Patient at Nutritional Risk: Does the Clinical Outcome Improve? - Full Text View

Sponsored by:	University Hospital Inselspital, Berne
Information provided by:	University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:	NCT00440453

Purpose

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.

Condition	Intervention	Phase
Malnutrition	Other: Nutritional therapy	Phase IV

MedlinePlus related topics: Nutritional Support

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Active Control, Single Group Assignment
Official Title:	Feeding the Patient at Nutritional Risk: Does the Clinical Outcome Improve?

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:

Length of stay [ Time Frame: after stay ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: 2 months after stay ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in body weight (measured day 1-2, 8, 28 and 56) and body composition (BMI, MAC, TSF) (measured day 1-2 and 8) [ Time Frame: during stay ] [ Designated as safety issue: No ]
Changes in muscle function (handgrip dynamometry) (measured day 1-2 and 8) [ Time Frame: during stay ] [ Designated as safety issue: No ]
Rate of accurately defined complications (infectious and non-infectious) (Table 2). Infectious are defined according to the US Centre of Disease Control [115]. [ Time Frame: during stay ] [ Designated as safety issue: No ]
Rate of accurately defined post-discharge complications (infectious and non-infectious) (Table 2) [ Time Frame: after stay ] [ Designated as safety issue: No ]
Rate of re-hospitalization (within 8 weeks after randomisation) [ Time Frame: after stay ] [ Designated as safety issue: No ]
Rate of mortality [ Time Frame: during and after stay ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	February 2007
Estimated Study Completion Date:	August 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention Normal hospital food
2: Experimental Nutritional treatment	Other: Nutritional therapy Nutritional therapy by dietician

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
patients that are already receiving, or are planned to receive parenteral nutrition
patients unable to understand the German language

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440453

Locations

Switzerland, BE
University hospital
Bern, BE, Switzerland, 3010

Sponsors and Collaborators

University Hospital Inselspital, Berne

Investigators

Principal Investigator:

Samuel W Iff, MD

University hospital Berne

More Information

Publications:

Kondrup J, Rasmussen HH, Hamberg O, Stanga Z; Ad Hoc ESPEN Working Group. Nutritional risk screening (NRS 2002): a new method based on an analysis of controlled clinical trials. Clin Nutr. 2003 Jun;22(3):321-36.

Allison SP. Malnutrition, disease, and outcome. Nutrition. 2000 Jul-Aug;16(7-8):590-3. Review. No abstract available.

Responsible Party:	University Hospital Inselspital ( Dr. med. Zeno Sanga )
Study ID Numbers:	EMS_CH_2007
Study First Received:	February 23, 2007
Last Updated:	June 6, 2008
ClinicalTrials.gov Identifier:	NCT00440453
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:

Internal medicine patients

Study placed in the following topic categories:

Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on January 14, 2009