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

Nutrition Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05276752
• Other study ID #: CHUB-Nutrition disorders
• Status: Recruiting
• Start date: October 12, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2022
• Source: Brugmann University Hospital
• Contact: Marie Claessens, MD
• Phone: 32472488182
• Email: Marie.CLAESSENS[@]chu-brugmann.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 224
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nutrition Disorders

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	Vital status (death/alive)	From 2016 till 2021
Secondary	Falls	Falls (yes/no)	From 2016 till 2021
Secondary	Fractures of upper and lower limbs and/or hip and/or vertebrae	Fractures of upper and lower limbs and/or hip and/or vertebrae (yes/no)	From 2016 till 2021
Secondary	Re-hospitalization	Unplanned readmission in hospital (yes/no)	From 2016 till 2021
Secondary	Institutionalization	Institutionalization (yes/no)	From 2016 till 2021
Secondary	All-cause admission in intensive care	All-cause admission in intensive care (yes/no)	From 2016 till 2021
Secondary	Mechanical ventilation	Mechanical ventilation (yes/no)	From 2016 till 2021
Secondary	Length of hospital stay time from admission to discharge	Length of hospital stay time from admission to discharge	From 2016 till 2021
Secondary	Sensitivity	Diagnostic performance indicators: the ability of a screening test to identify malnourished patients according to the GLIM criteria.	From 2016 till 2021
Secondary	Specificity	Diagnostic performance indicators: the ability of a screening test to identify non-malnourished patients according to the GLIM criteria.	From 2016 till 2021
Secondary	Positive predictive value (PPV)	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
Secondary	Negative predictive value (NPV)	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
Secondary	Area under the ROC curve (AUC)	A measure of the precision of a quantitative diagnostic test, which gives equal weight to sensitivity and specificity.	From 2016 till 2021