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

Malnutrition Clinical Trial

— EMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00440453
• Other study ID #: EMS_CH_2007
• Status: Completed
• Phase: Phase 4
• First received: February 23, 2007
• Last updated: September 22, 2011
• Start date: February 2007
• Est. completion date: August 2008

Study information

• Verified date: September 2011
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnutrition

Intervention

Other:
• Nutritional therapy
Nutritional therapy by dietician

Locations

Country	Name	City	State
Switzerland	University hospital	Bern	BE

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

Allison SP. Malnutrition, disease, and outcome. Nutrition. 2000 Jul-Aug;16(7-8):590-3. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay		after stay	No
Secondary	Quality of life		2 months after stay	No
Secondary	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	No
Secondary	Changes in muscle function (handgrip dynamometry) (measured day 1-2 and 8)		during stay	No
Secondary	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	No
Secondary	Rate of accurately defined post-discharge complications (infectious and non-infectious) (Table 2)		after stay	No
Secondary	Rate of re-hospitalization (within 8 weeks after randomisation)		after stay	No
Secondary	Rate of mortality		during and after stay	No