Clinical trial NCT00440453: Feeding the Patient at Nutritional Risk: Does the Clinical Outcome Improve?
Official title: Feeding the Patient at Nutritional Risk: Does the Clinical Outcome Improve?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malnutrition
Keywords: Internal medicine patients
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2007-02-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Length of stay
timeFrame: after stay
Secondary outcomes:
measure: Quality of life
timeFrame: 2 months after stay
measure: Changes in body weight (measured day 1-2, 8, 28 and 56) and body composition (BMI, MAC, TSF) (measured day 1-2 and 8)
timeFrame: during stay
measure: Changes in muscle function (handgrip dynamometry) (measured day 1-2 and 8)
timeFrame: during stay
measure: Rate of accurately defined complications (infectious and non-infectious) (Table 2). Infectious are defined according to the US Centre of Disease Control [115].
timeFrame: during stay
measure: Rate of accurately defined post-discharge complications (infectious and non-infectious) (Table 2)
timeFrame: after stay
measure: Rate of re-hospitalization (within 8 weeks after randomisation)
timeFrame: after stay
measure: Rate of mortality
timeFrame: during and after stay
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University hospital
state: BE
Study officials:
affiliation: University hospital Berne
name: Samuel W Iff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.