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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05918900
Other study ID # BB 073/23
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 5, 2023
Est. completion date September 22, 2023

Study information

Verified date December 2023
Source University Medicine Greifswald
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to study the presence and consequences of malnutrition risk in hospitalized internal medicine patients. The main questions it aims to answer are: 1. How many patients are at risk of malnutrition at admission? 2. Is there a link between an existing malnutrition risk and nutrition therapy that the patients receive? 3. Is there a link between an existing malnutrition risk and clinical outcome (e.g. length of hospital stay, mortality, need for rehospitalization)? Participants will be screened for malnutrition risk at admission using a validated questionnaire (Nutritional Risk Screening 2002). All relevant data regarding hospital stay will be obtained from the clinical information system after discharge.


Description:

Malnutrition is associated with adverse clinical outcome in hospitalized patients. Therefore, systematic screening for malnutrition risk at admission is recommended by almost all medical expert societies to identify patients who will benefit from nutritional therapy. Although clinical and economic benefit of systematic malnutrition screening have been shown in various settings and for different patient groups, such screening is still not mandatory in most countries. In part, establishment of malnutrition screening is hampered by discrepant findings on the prevalence of malnutrition risk and the lack of evidence on a local level. Hence, in this observational study the investigators examine the results of systematic malnutrition screening in internal medicine patients admitted to a university hospital in Northeast Germany. In particular, the investigators aim to determine the prevalence of malnutrition risk at hospital admission, the association between malnutrition risk and nutrition therapy as well as clinical outcome in different disciplines of internal medicine. For this purpose, all patients undergo screening for malnutrition risk at admission using a validated instrument (Nutritional Risk Screening 2002). All relevant data regarding the patients' hospital stay will be obtained from the clinical information system after discharge.


Recruitment information / eligibility

Status Completed
Enrollment 323
Est. completion date September 22, 2023
Est. primary completion date September 22, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - hospital admission for gastrointestinal, endocrine, rheumatic, or nephrological condition - provision of informed consent Exclusion Criteria: - inability to provide consent - unfeasibility to perform malnutrition screening within 48h after admission

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany University Medicine Greifswald Greifswald

Sponsors (1)

Lead Sponsor Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall presence of malnutrition risk Prevalence of malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, in all internal medicine patients at hospital admission. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk. Baseline
Secondary Presence of malnutrition risk in gastroenterology Prevalence of malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, in patients with gastrointestinal disease at hospital admission. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk. Baseline
Secondary Presence of malnutrition risk in endocrinology Prevalence of malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, in patients with endocrine disease at hospital admission. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk. Baseline
Secondary Presence of malnutrition risk in rheumatology Prevalence of malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, in patients with rheumatic disease at hospital admission. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk. Baseline
Secondary Presence of malnutrition risk in nephrology Prevalence of malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, in patients with nephrological disease at hospital admission. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk. Baseline
Secondary Relation of malnutrition risk to nutritional consultation Association between malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, and number of nutritional consultations. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk. Baseline
Secondary Relation of malnutrition risk to nutritional diagnosis Association between malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, and nutritional diagnosis resulting from nutritional assessment by an expert dietitian. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk. Baseline
Secondary Relation of malnutrition risk to intensive care treatment Association between malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, and admission to an intensive care unit. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk. Baseline
Secondary Relation of malnutrition risk to intermediate care treatment Association between malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, and admission to an intermediate care unit. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk. Baseline
Secondary Relation of malnutrition risk to mortality Association between malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, and in-hospital mortality. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk. Baseline
Secondary Relation of malnutrition risk to length of hospital stay Association between malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, and length of hospital stay measured in days. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk. Baseline
Secondary Relation of malnutrition risk and 30-day readmission Association between malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, and unplanned hospital readmission within 30 days after discharge. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk. Baseline
Secondary Relation of malnutrition risk and 90-day readmission Association between malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, and unplanned hospital readmission within 90 days after discharge. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk. Baseline
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