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

I

Insel Gruppe AG, University Hospital Bern

Status and phase

Completed
Phase 4

Conditions

Malnutrition

Treatments

Other: Nutritional therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00440453
EMS_CH_2007

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

200 participants in 2 patient groups

1
No Intervention group
Description:
Normal hospital food
2
Experimental group
Description:
Nutritional treatment
Treatment:
Other: Nutritional therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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