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Completed

NCT Number: NCT00440453

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.

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University hospital

Bern, Canton of Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutritional therapy

Other

Nutritional therapy by dietician

Primary outcomes

  1. Length of stay

    Time frame: after stay

Secondary outcomes

  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

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Acronym: EMS

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 27, 2007
Registry last updated
Sep 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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