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

Sponsor
Brugmann University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05276752
Collaborator
(none)
224
1
14.6
15.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    224 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Short- and Long-term Health Adverse Outcomes Associated With Nutrition Disorders and Nutrition Related Conditions in Hospitalized Older People
    Actual Study Start Date :
    Oct 12, 2021
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. All-cause mortality [From 2016 till 2021]

      Vital status (death/alive)

    Secondary Outcome Measures

    1. Falls [From 2016 till 2021]

      Falls (yes/no)

    2. Fractures of upper and lower limbs and/or hip and/or vertebrae [From 2016 till 2021]

      Fractures of upper and lower limbs and/or hip and/or vertebrae (yes/no)

    3. Re-hospitalization [From 2016 till 2021]

      Unplanned readmission in hospital (yes/no)

    4. Institutionalization [From 2016 till 2021]

      Institutionalization (yes/no)

    5. All-cause admission in intensive care [From 2016 till 2021]

      All-cause admission in intensive care (yes/no)

    6. Mechanical ventilation [From 2016 till 2021]

      Mechanical ventilation (yes/no)

    7. Length of hospital stay time from admission to discharge [From 2016 till 2021]

      Length of hospital stay time from admission to discharge

    8. Sensitivity [From 2016 till 2021]

      Diagnostic performance indicators: the ability of a screening test to identify malnourished patients according to the GLIM criteria.

    9. Specificity [From 2016 till 2021]

      Diagnostic performance indicators: the ability of a screening test to identify non-malnourished patients according to the GLIM criteria.

    10. Positive predictive value (PPV) [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.

    11. Negative predictive value (NPV) [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.

    12. Area under the ROC curve (AUC) [From 2016 till 2021]

      A measure of the precision of a quantitative diagnostic test, which gives equal weight to sensitivity and specificity.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Brugmann Brussels Belgium

    Sponsors and Collaborators

    • Brugmann University Hospital

    Investigators

    • Principal Investigator: Marie Claessens, CHU Brugmann

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Murielle Surquin, Head of geriatry department, Brugmann University Hospital
    ClinicalTrials.gov Identifier:
    NCT05276752
    Other Study ID Numbers:
    • CHUB-Nutrition disorders
    First Posted:
    Mar 11, 2022
    Last Update Posted:
    Mar 11, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 11, 2022