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

NCT00440453 | Completed Phase 4

• 1 other identifier: EMS_CH_2007
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition

Keywords

Internal medicine patients

Outcome Measures

Primary Outcomes (1)

• Length of stay

  after stay

Secondary Outcomes (7)

• Quality of life

  2 months after stay

• Changes in body weight (measured day 1-2, 8, 28 and 56) and body composition (BMI, MAC, TSF) (measured day 1-2 and 8)

  during stay

• Changes in muscle function (handgrip dynamometry) (measured day 1-2 and 8)

  during stay

• Rate of accurately defined complications (infectious and non-infectious) (Table 2). Infectious are defined according to the US Centre of Disease Control [115].

  during stay

• Rate of accurately defined post-discharge complications (infectious and non-infectious) (Table 2)

  after stay

Study Arms (2)

1

NO INTERVENTION

Normal hospital food

2

EXPERIMENTAL

Nutritional treatment

Other: Nutritional therapy

Interventions

Nutritional therapy OTHER

Nutritional therapy by dietician

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients coming on station

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

University hospital

Bern, Canton of Bern, 3010, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 12765673 BACKGROUND

• 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.

  PMID: 10906565 BACKGROUND

MeSH Terms

Conditions

Malnutrition

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Samuel W Iff, MD

  University hospital Berne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 23, 2007
• First Posted: February 27, 2007
• Study Start: February 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: August 1, 2008
• Last Updated: September 23, 2011

Record last verified: 2011-09

Locations

CH (1)