- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Contatto studio
- Nome: Marie Claessens, MD
- Numero di telefono: 32472488182
- Email: marie.claessens@chu-brugmann.be
Luoghi di studio
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Brussels, Belgio
- Reclutamento
- CHU Brugmann
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Contatto:
- Marie Claessens, MD
- Numero di telefono: 32472488182
- Email: marie.claessens@chu-brugmann.be
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Coorte
- Prospettive temporali: Retrospettiva
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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All-cause mortality
Lasso di tempo: From 2016 till 2021
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Vital status (death/alive)
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From 2016 till 2021
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Falls
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: From 2016 till 2021
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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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Marie Claessens, CHU Brugmann
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CHUB-Nutrition disorders
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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