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

September 22, 2011 updated by: University Hospital Inselspital, Berne
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • BE
      • Bern, BE, Switzerland, 3010
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of stay
Time Frame: after stay
after stay

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: 2 months after stay
2 months after stay
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
during stay
Changes in muscle function (handgrip dynamometry) (measured day 1-2 and 8)
Time Frame: during stay
during stay
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
during stay
Rate of accurately defined post-discharge complications (infectious and non-infectious) (Table 2)
Time Frame: after stay
after stay
Rate of re-hospitalization (within 8 weeks after randomisation)
Time Frame: after stay
after stay
Rate of mortality
Time Frame: during and after stay
during and after stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Investigators

  • Principal Investigator: Samuel W Iff, MD, University Hospital Berne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

February 23, 2007

First Submitted That Met QC Criteria

February 23, 2007

First Posted (Estimate)

February 27, 2007

Study Record Updates

Last Update Posted (Estimate)

September 23, 2011

Last Update Submitted That Met QC Criteria

September 22, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMS_CH_2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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