- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05276752
Short- and Long-term Health Adverse Outcomes Associated With Nutrition Disorders and Nutrition Related Conditions in Hospitalized Older People
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
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Marie Claessens, MD
- Phone Number: 32472488182
- Email: marie.claessens@chu-brugmann.be
Study Locations
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Brussels, Belgium
- Recruiting
- CHU Brugmann
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Contact:
- Marie Claessens, MD
- Phone Number: 32472488182
- Email: marie.claessens@chu-brugmann.be
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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)
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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)
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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)
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From 2016 till 2021
|
Length of hospital stay time from admission to discharge
Time Frame: From 2016 till 2021
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Length of hospital stay time from admission to discharge
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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.
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From 2016 till 2021
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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.
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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.
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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.
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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
Sponsor
Investigators
- Principal Investigator: Marie Claessens, CHU Brugmann
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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