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

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ClinicalTrials.gov Identifier: NCT00440453
Recruitment Status : Completed
First Posted : February 27, 2007
Last Update Posted : September 23, 2011
Sponsor:
Information provided by:
University Hospital Inselspital, Berne

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.

Condition or disease Intervention/treatment Phase
Malnutrition Other: Nutritional therapy Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Feeding the Patient at Nutritional Risk: Does the Clinical Outcome Improve?
Study Start Date : February 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: 1
Normal hospital food
Experimental: 2
Nutritional treatment
Other: Nutritional therapy
Nutritional therapy by dietician



Primary Outcome Measures :
  1. Length of stay [ Time Frame: after stay ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 2 months after stay ]
  2. 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 ]
  3. Changes in muscle function (handgrip dynamometry) (measured day 1-2 and 8) [ Time Frame: during stay ]
  4. 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 ]
  5. Rate of accurately defined post-discharge complications (infectious and non-infectious) (Table 2) [ Time Frame: after stay ]
  6. Rate of re-hospitalization (within 8 weeks after randomisation) [ Time Frame: after stay ]
  7. Rate of mortality [ Time Frame: during and after stay ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Dr. med. Zeno Sanga, University Hospital Inselspital
ClinicalTrials.gov Identifier: NCT00440453     History of Changes
Other Study ID Numbers: EMS_CH_2007
First Posted: February 27, 2007    Key Record Dates
Last Update Posted: September 23, 2011
Last Verified: September 2011

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

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders