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

This study has been completed.
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00440453
First received: February 23, 2007
Last updated: September 22, 2011
Last verified: September 2011
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Feeding the Patient at Nutritional Risk: Does the Clinical Outcome Improve?

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 2 months after stay ] [ Designated as safety issue: No ]
  • 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 ]

Enrollment: 200
Study Start Date: February 2007
Study Completion Date: August 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Normal hospital food
Experimental: 2
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
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:

Responsible Party: Dr. med. Zeno Sanga, University Hospital Inselspital
ClinicalTrials.gov Identifier: NCT00440453     History of Changes
Other Study ID Numbers: EMS_CH_2007
Study First Received: February 23, 2007
Last Updated: September 22, 2011
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
Internal medicine patients

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on May 22, 2013