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

Primary Purpose

Malnutrition

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Nutritional therapy
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition focused on measuring Internal medicine patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

1

2

Arm Description

Normal hospital food

Nutritional treatment

Outcomes

Primary Outcome Measures

Length of stay

Secondary Outcome Measures

Quality of life
Changes in body weight (measured day 1-2, 8, 28 and 56) and body composition (BMI, MAC, TSF) (measured day 1-2 and 8)
Changes in muscle function (handgrip dynamometry) (measured day 1-2 and 8)
Rate of accurately defined complications (infectious and non-infectious) (Table 2). Infectious are defined according to the US Centre of Disease Control [115].
Rate of accurately defined post-discharge complications (infectious and non-infectious) (Table 2)
Rate of re-hospitalization (within 8 weeks after randomisation)
Rate of mortality

Full Information

First Posted
February 23, 2007
Last Updated
September 22, 2011
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT00440453
Brief Title
Feeding the Patient at Nutritional Risk: Does the Clinical Outcome Improve?
Acronym
EMS
Official Title
Feeding the Patient at Nutritional Risk: Does the Clinical Outcome Improve?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Internal medicine patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Normal hospital food
Arm Title
2
Arm Type
Experimental
Arm Description
Nutritional treatment
Intervention Type
Other
Intervention Name(s)
Nutritional therapy
Intervention Description
Nutritional therapy by dietician
Primary Outcome Measure Information:
Title
Length of stay
Time Frame
after stay
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
2 months after stay
Title
Changes in body weight (measured day 1-2, 8, 28 and 56) and body composition (BMI, MAC, TSF) (measured day 1-2 and 8)
Time Frame
during stay
Title
Changes in muscle function (handgrip dynamometry) (measured day 1-2 and 8)
Time Frame
during stay
Title
Rate of accurately defined complications (infectious and non-infectious) (Table 2). Infectious are defined according to the US Centre of Disease Control [115].
Time Frame
during stay
Title
Rate of accurately defined post-discharge complications (infectious and non-infectious) (Table 2)
Time Frame
after stay
Title
Rate of re-hospitalization (within 8 weeks after randomisation)
Time Frame
after stay
Title
Rate of mortality
Time Frame
during and after stay

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel W Iff, MD
Organizational Affiliation
University hospital Berne
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital
City
Bern
State/Province
BE
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
12765673
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.
Results Reference
background
PubMed Identifier
10906565
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.
Results Reference
background

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

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