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NCT Number: NCT00673530

Clinical Nutrition Concept for Hospitalized Patients With Malnutrition

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.

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Key information

Conditions

Malnutrition Hyperphagia Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Städtisches Klinikum Ansbach, Ansbach, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

evidence based clinical nutrition concept

Behavioral

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 names: Optimized clinical nutrition concept

Care as usual

Behavioral

Unchanged treatment of hospital patients without interference by the study.

Primary outcomes

  1. Length of hospital stay

    Time frame: At least 3 months each group, 6 months for both groups

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study 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

Acronym: NUTRICORE

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
May 7, 2008
Registry last updated
Mar 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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