Short- and Long-term Health Adverse Outcomes Associated With Nutrition Disorders and Nutrition Related Conditions in Hospitalized Older People

March 3, 2022 updated by: Murielle Surquin, Brugmann University Hospital

Malnutrition is associated with health adverse outcomes such as higher risk of mobility disability, falls and, fractures and higher mortality. Malnutrition had been defined as "a state resulting from lack of intake or uptake of nutrition that leads to altered body composition (decreased fat free mass) and body cell mass leading to diminished physical and mental function and impaired clinical outcome from disease". In 2018, the European Society for Clinical Nutrition and Metabolism (ESPEN) revisited nutrition and nutrition-related conditions definitions in the ESPEN guidelines on definitions and terminology of clinical nutrition based on the findings of the last decades. Nutrition disorders and nutrition related conditions were divided in 5 categories: Malnutrition/undernutrition, sarcopenia and frailty, overweight and obesity, micronutrients abnormalities, and refeeding syndrome. The definition of malnutrition based on the Global Leadership Initiative on Malnutrition (GLIM) criteria is globally accepted by de scientific community since this was launched in 2019. The presence of at least one phenotypic (i.e., nonintentional weight loss, low body mass index or low muscle mass) and one etiologic criterion (i.e., reduced food intake or inflammation) were required to define malnutrition.

Malnutrition is a common pathological condition in older adults that can further influence and aggravate health-related muscle decline. Sarcopenia is known as a natural progressive decline in skeletal muscles occurring with age, with an age-related decline in muscle strength. According to the criteria published in 2019 by the European Working Group on Sarcopenia in Older People (EWGSOP2), this process is defined by the presence of low muscle strength and low muscle mass.

Patients in acute care are likely to present higher stay and risk of mortality. However, the mortality have rarely been applied in acute care, due to difficulties to administer Dual X-ray Absorptiometry (DXA), the gold standard method for muscle mass in acute care. Pragmatic approaches to assess nutrition and nutrition-related condition are urgently needed to provide better quality of care in clinical practice in geriatric medicine.

The primary objective of this study is to determine the impact of nutrition disorders and nutrition-related conditions at baseline (admission in hospitalization) on the all-causes mortality risk in hospitalized older people.

Secondarily, this study evaluates their impact on other health adverse outcomes: falls, fractures, rehospitalization, institutionalization, all-cause admission in intensive care, length of hospital stay, length of ventilation and USI stay.

Finally, the diagnostic performance indicators of the Mini Nutritional Assessment (MNA-SF) and the Geriatric Nutritional Risk Index (GNRI) for malnutrition assessment following the GLIM criteria were calculated.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

224

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients aged ≥60 and over admitted to the geriatric healthcare unit and/or the COVID-19 unit of the CHU Brugmann Hospital, between 01/01/2016 and 12/10/2021.

Description

Inclusion Criteria:

  • Patients aged ≥60 and over admitted to the geriatric healthcare unit and/or the COVID-19 unit of the CHU Brugmann Hospital, between 01/01/2016 and 12/10/2021.
  • Patients who had the assessment of nutrition disorders and/or nutrition related conditions available during their hospital admission.

Exclusion Criteria:

- No exclusion criteria based on demographical or medical data were applied.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: From 2016 till 2021
Vital status (death/alive)
From 2016 till 2021

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Falls
Time Frame: From 2016 till 2021
Falls (yes/no)
From 2016 till 2021
Fractures of upper and lower limbs and/or hip and/or vertebrae
Time Frame: From 2016 till 2021
Fractures of upper and lower limbs and/or hip and/or vertebrae (yes/no)
From 2016 till 2021
Re-hospitalization
Time Frame: From 2016 till 2021
Unplanned readmission in hospital (yes/no)
From 2016 till 2021
Institutionalization
Time Frame: From 2016 till 2021
Institutionalization (yes/no)
From 2016 till 2021
All-cause admission in intensive care
Time Frame: From 2016 till 2021
All-cause admission in intensive care (yes/no)
From 2016 till 2021
Mechanical ventilation
Time Frame: From 2016 till 2021
Mechanical ventilation (yes/no)
From 2016 till 2021
Length of hospital stay time from admission to discharge
Time Frame: From 2016 till 2021
Length of hospital stay time from admission to discharge
From 2016 till 2021
Sensitivity
Time Frame: From 2016 till 2021
Diagnostic performance indicators: the ability of a screening test to identify malnourished patients according to the GLIM criteria.
From 2016 till 2021
Specificity
Time Frame: From 2016 till 2021
Diagnostic performance indicators: the ability of a screening test to identify non-malnourished patients according to the GLIM criteria.
From 2016 till 2021
Positive predictive value (PPV)
Time Frame: From 2016 till 2021
Positive predictive value is the proportion of positive screening test results that are true positives for the diagnosis of malnutrition according to GLIM criteria.
From 2016 till 2021
Negative predictive value (NPV)
Time Frame: From 2016 till 2021
Negative predictive value (NPV) is the proportion of negative screening test results that are true negative for the diagnosis of malnutrition according to the GLIM criteria.
From 2016 till 2021
Area under the ROC curve (AUC)
Time Frame: From 2016 till 2021
A measure of the precision of a quantitative diagnostic test, which gives equal weight to sensitivity and specificity.
From 2016 till 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marie Claessens, CHU Brugmann

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

March 3, 2022

First Submitted That Met QC Criteria

March 3, 2022

First Posted (Actual)

March 11, 2022

Study Record Updates

Last Update Posted (Actual)

March 11, 2022

Last Update Submitted That Met QC Criteria

March 3, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUB-Nutrition disorders

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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