Clinical Nutrition Concept for Hospitalized Patients With Malnutrition (NUTRICORE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00673530
Recruitment Status : Completed
First Posted : May 7, 2008
Last Update Posted : March 8, 2016
Information provided by:
Charite University, Berlin, Germany

Brief Summary:
The purpose of this study is to determine whether there is a positive correlation between an evidence based clinical nutrition concept and relevant clinical outcomes in malnourished hospitalised patients when severity of disease is adjusted.

Condition or disease Intervention/treatment Phase
Malnutrition Behavioral: evidence based clinical nutrition concept Behavioral: care as usual Not Applicable

Detailed Description:

Patients have been consecutively screened at admission by SGA (Subjective-Global-Assessment)-Score and NRS 2002 (Nutritional-Risk-Screening)-Score in the departments of surgery and internal medicine. The nutrition status of each patient is combined with clinical data, utilization data and direct costs on the basis of clinical homogenous patient clusters. Risk-Adjustment was provided by the Disease-Staging-Scale (MEDSTAT/Thomson Healthcare, Ann Arbor MI), which allows patient classification by diagnosis and co morbidities including age and gender. The risk adjustment scales run by routine data sets from german inpatient G-DRG system. In the control period the effects of usual nutrition care are documented. During the intervention period an implementation of an interdisciplinary evidence-based guideline for screening and clinical nutrition was introduced in each participating hospital.

The issue is to describe the relation between risk-adjusted malnutrition status and clinical outcomes and costs.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10242 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of an Evidence Based Clinical Nutrition Concept on Clinical Outcomes in Hospitalized Patients With Malnutrition When Severity of Disease is Taken Into Consideration
Study Start Date : July 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
evidence based clinical nutrition concept
Behavioral: evidence based clinical nutrition concept
The evidence based nutrition concept comprise a routine malnutrition screening for hospitalized patients, the implementation of an evidence based guideline for clinical nutrition in the participating hospital, education training of the clinical staff and thereby optimal clinical nutrition for malnourished hospitalized patients.
Other Name: Optimized clinical nutrition concept
care as usual
Behavioral: care as usual
Unchanged treatment of hospital patients without interference by the study.

Primary Outcome Measures :
  1. Length of hospital stay [ Time Frame: At least 3 months each group, 6 months for both groups ]

Secondary Outcome Measures :
  1. all cause hospital mortality [ Time Frame: At least 3 months each group, 6 months for both groups ]
  2. complication rate [ Time Frame: At least 3 months each group, 6 months for both groups ]
  3. hospital readmission rate [ Time Frame: 1 Month each group ]
  4. Economic devices (direct costs of inpatient care and reimbursement) [ Time Frame: At least 4 months each group, 7 months for both groups ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • at least 18 years of age
  • internal or operative admission diagnosis in participating hospitals

Exclusion Criteria:

  • Patients with demand for emergency care
  • Patients with demand for intensive care
  • Patients with hospital day-care
  • Patients unwilling to participate or unable to comply with the protocol in the control group

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00673530

Städtisches Klinikum Ansbach
Ansbach, Germany
Kliniken Südliche Weinstraße Landau
Bad Bergzabern, Germany
Evangelische und Johanniter Kliniken
Duisburg, Germany
Kreiskrankenhaus Hameln
Hameln, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
Study Director: Stefan N Willich, Prof. Dr. Charite University, Berlin, Germany

Responsible Party: Stefan N. Willich, Charité University Medical Center, Berlin, Germany Identifier: NCT00673530     History of Changes
Other Study ID Numbers: NUTRICORE
First Posted: May 7, 2008    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: February 2009

Keywords provided by Charite University, Berlin, Germany:
Hospital malnutrition
Nutritional Status
Nutrition Assessment
Enteral Nutrition
Parenteral Nutrition
Severity of illness index
cost analysis

Additional relevant MeSH terms:
Nutrition Disorders