Nutrition Screening - Route to a More Practical Method

Internal Medicine Clinical Trial

Official title:

Nutrition Screening - Route to a More Practical Method

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05546034
• Other study ID #: PKL-127
• Status: Completed
• Start date: September 6, 2021
• Est. completion date: March 23, 2022

Study information

• Verified date: September 2022
• Source: University of Tartu
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observational study. Comparison of existing nutritional screening tools based on questionnaires with blood tests already performed on a routine basis.

No intervention undertaken.

Description:

Nutrition screening is of established benefit but is difficult to ensure in ordinary clinical practice. It is relatively labour intensive. The investigation aims to determine whether routinely collected laboratory data could provide comparable information without the need for personnel time. It is known that individual blood tests do not provide sufficient sensitivity or specificity but it is hypothesised that combinations of tests could do so.

Included subjects are those admitted to the University Hospital department of internal medicine. All are eligible other than those subject to protective isolation for infection control (COVID, etc). Data collection is in the form of questionnaires to permit the calculation of 3 tools widely used for screening for malnutrition and malnutrition risk, namely the Malnutrition Universal Screening Tool (MUST), the Nutrition Risk Screening 2002 (NRS-2002) and the Subjective Global Assessment (SGA). Nutritional status is documented by the patient's status according to the international definition provided by the Global Leadership Initiative on Malnutrition (GLIM).

The blood tests already performed on a routine basis are captured to go alongside the nutrition screening tools.

Analysis will aim to determine whether combinations of laboratory data can simulate or replicate the information provided by MUST and NRS2002.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 23, 2022
• Est. primary completion date: March 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

In-patient in department of internal medicine

Exclusion Criteria:

Unable to complete questionnaire or in protective isolation

Related Conditions & MeSH terms

• Internal Medicine

Intervention

Diagnostic Test:
• Standard nutrition screening tools to be compared with routine blood tests
None other than completion of questionnaires one of which would be done in routine practice

Locations

Country	Name	City	State
Estonia	Tartu Ülikooli Kliinikum	Tartu	Tartumaa

Sponsors (1)

Lead Sponsor	Collaborator
University of Tartu

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of new nutrition risk screening tool (devised from 200 patients) by validation in 100 contemporaneous patients in comparison with established screening tools (MUST, NRS-2002 and SGA) and malnutrition defined by GLIM.	Established tools for screening and assessing nutritional status are utilised. These are the Malnutrition Universal Screening Tool (MUST), the Nutrition Risk Screening-2002 (NRS-2002), the Subjective Global Assessment (SGA) and the Global Leadership Initiative on Malnutrition (GLIM). Data from laboratory testing that has already been performed on these patients is extracted from their hospital records. It is hypothesised that multivariate analysis of indicative parameters will identify 6 to 12 tests that can be combined (with appropriate weighting) into a new predictive score.; 300 sets of patient data will be divided on a randomised basis into a group of 200 from whom the prospective new scoring system will be devised, and a group of 100 in whom the score will be tested for validity against NRS-2002.	Within 6 months of completion of recruitment
Secondary	Validation of new score against GLIM	The intended new score will be tested against GLIM. The primary validation is against NRS-2002 as the score is intended as a screening tool for high risk of malnutrition, but it is important to determine whether it is also a test of established malnutrition.	Within 6 months of completion of recruitment