- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Marie Claessens, MD
- Numéro de téléphone: 32472488182
- E-mail: marie.claessens@chu-brugmann.be
Lieux d'étude
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Brussels, Belgique
- Recrutement
- CHU Brugmann
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Contact:
- Marie Claessens, MD
- Numéro de téléphone: 32472488182
- E-mail: marie.claessens@chu-brugmann.be
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Rétrospective
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
All-cause mortality
Délai: From 2016 till 2021
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Vital status (death/alive)
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From 2016 till 2021
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Falls
Délai: From 2016 till 2021
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Falls (yes/no)
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From 2016 till 2021
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Fractures of upper and lower limbs and/or hip and/or vertebrae
Délai: From 2016 till 2021
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Fractures of upper and lower limbs and/or hip and/or vertebrae (yes/no)
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From 2016 till 2021
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Re-hospitalization
Délai: From 2016 till 2021
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Unplanned readmission in hospital (yes/no)
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From 2016 till 2021
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Institutionalization
Délai: From 2016 till 2021
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Institutionalization (yes/no)
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From 2016 till 2021
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All-cause admission in intensive care
Délai: From 2016 till 2021
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All-cause admission in intensive care (yes/no)
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From 2016 till 2021
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Mechanical ventilation
Délai: From 2016 till 2021
|
Mechanical ventilation (yes/no)
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From 2016 till 2021
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Length of hospital stay time from admission to discharge
Délai: 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
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Sensitivity
Délai: From 2016 till 2021
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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
Délai: From 2016 till 2021
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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
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Positive predictive value (PPV)
Délai: From 2016 till 2021
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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
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Negative predictive value (NPV)
Délai: From 2016 till 2021
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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
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Area under the ROC curve (AUC)
Délai: From 2016 till 2021
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A measure of the precision of a quantitative diagnostic test, which gives equal weight to sensitivity and specificity.
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From 2016 till 2021
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Marie Claessens, CHU Brugmann
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CHUB-Nutrition disorders
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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