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

February 23, 2007
September 22, 2011
February 2007
June 2008   (final data collection date for primary outcome measure)
Length of stay [ Time Frame: after stay ] [ Designated as safety issue: No ]
  • Length of stay
  • Quality of life
Complete list of historical versions of study NCT00440453 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Changes in body weight (measured day 1-2, 8, 28 and 56) and body composition (BMI, MAC, TSF) (measured day 1-2 and 8)
  • Changes in muscle function (handgrip dynamometry) (measured day 1-2 and 8)
  • Rate of accurately defined complications (infectious and non-infectious) (Table 2). Infectious are defined according to the US Centre of Disease Control [115].
  • Rate of accurately defined post-discharge complications (infectious and non-infectious) (Table 2)
  • Rate of re-hospitalization (within 8 weeks after randomisation)
  • Rate of mortality
Not Provided
Not Provided
 
Feeding the Patient at Nutritional Risk: Does the Clinical Outcome Improve?
Feeding the Patient at Nutritional Risk: Does the Clinical Outcome Improve?

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Malnutrition
Other: Nutritional therapy
Nutritional therapy by dietician
  • No Intervention: 1
    Normal hospital food
  • Experimental: 2
    Nutritional treatment
    Intervention: Other: Nutritional therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
August 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00440453
EMS_CH_2007
No
Dr. med. Zeno Sanga, University Hospital Inselspital
University Hospital Inselspital, Berne
Not Provided
Principal Investigator: Samuel W Iff, MD University hospital Berne
University Hospital Inselspital, Berne
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP