Feeding the Patient at Nutritional Risk: Does the Clinical Outcome Improve?
NCT ID: NCT00440453
Last Updated: 2011-09-23
Study Results
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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COMPLETED
PHASE4
200 participants
INTERVENTIONAL
2007-02-28
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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1
Normal hospital food
No interventions assigned to this group
2
Nutritional treatment
Nutritional therapy
Nutritional therapy by dietician
Interventions
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Nutritional therapy
Nutritional therapy by dietician
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
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
Countries
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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.
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.
Other Identifiers
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EMS_CH_2007
Identifier Type: -
Identifier Source: org_study_id