Skip to content

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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00440453
Acronym
EMS
Enrollment
200
Registered
2007-02-27
Start date
2007-02-28
Completion date
2008-08-31
Last updated
2011-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition

Keywords

Internal medicine patients

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.

Interventions

Nutritional therapy by dietician

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Length of stayafter stay

Secondary

MeasureTime frame
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
Quality of life2 months after stay
Rate of re-hospitalization (within 8 weeks after randomisation)after stay
Rate of mortalityduring and after stay
Rate of accurately defined post-discharge complications (infectious and non-infectious) (Table 2)after stay

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026