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

NCT ID: NCT00440453

Last Updated: 2011-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Normal hospital food

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Nutritional treatment

Group Type EXPERIMENTAL

Nutritional therapy

Intervention Type OTHER

Nutritional therapy by dietician

Interventions

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Nutritional therapy

Nutritional therapy by dietician

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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University Hospital Inselspital

Principal Investigators

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Samuel W Iff, MD

Role: PRINCIPAL_INVESTIGATOR

University hospital Berne

Locations

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University hospital

Bern, Canton of Bern, Switzerland

Site Status

Countries

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Switzerland

References

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Kondrup J, Rasmussen HH, Hamberg O, Stanga Z; Ad Hoc ESPEN Working Group. Nutritional risk screening (NRS 2002): a new method based on an analysis of controlled clinical trials. Clin Nutr. 2003 Jun;22(3):321-36. doi: 10.1016/s0261-5614(02)00214-5.

Reference Type BACKGROUND
PMID: 12765673 (View on PubMed)

Allison SP. Malnutrition, disease, and outcome. Nutrition. 2000 Jul-Aug;16(7-8):590-3. doi: 10.1016/s0899-9007(00)00368-3. No abstract available.

Reference Type BACKGROUND
PMID: 10906565 (View on PubMed)

Other Identifiers

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EMS_CH_2007

Identifier Type: -

Identifier Source: org_study_id