Nutritional Support in Hospitalized Patients (COCONUT)
3 de junio de 2026 actualizado por: Michele Barone, University of Bari
Nutrition Day: Prevalenza Della Nutrizione Artificiale Nei Pazienti Ospedalizzati e Appropriatezza Prescrittiva a Supporto Della Valutazione Dei Costi e Della Programmazione Dei Consumi.
To evaluate the prevalence of hospitalized patients who receive artificial nutrition, the type of patients who resort to artificial nutrition, the appropriateness of the latter in terms of specificity with respect to the clinical condition, and the adequacy of the caloric-protein intake provided to the patient.
Descripción general del estudio
Estado
Terminado
Descripción detallada
Despite detailed recommendations provided by international scientific societies, numerous studies highlight substantial variability and deficiencies in clinical practice, notably delays in initiating artificial nutrition (AN), inadequate caloric and protein dosing, and disparities in treatment across patient groups.
Unfortunately, applying the general recommendations to nutritional therapy for polymorbid patients is particularly challenging for healthcare providers without specific nutrition training, as disease-specific quantitative and qualitative nutritional requirements must be considered.
In this report, we present results obtained from data collected on hospitalized patients undergoing AN across 35 medical and surgical wards and the intensive care unit of a university hospital in Southern Italy.
In all these cases, the decisions regarding the type (enteral/parenteral) and the intensity (calories/proteins) of the nutritional interventions observed were made by the physicians working on the wards.
This study describes the application of AN in real-world hospital settings, identifying the main critical issues and suggesting possible interventions to improve clinical practice.
Tipo de estudio
De observación
Inscripción (Actual)
578
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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BA
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Bari, BA, Italia, 70124
- Polyclinic University Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
This observational, cross-sectional study evaluated the prevalence of patients receiving artificial nutrition and the appropriateness of this treatment at the Bari Polyclinic University Hospital.
All patients were allocated to 35 different medical and surgical wards or the intensive care unit (ICU).
Descripción
Inclusion Criteria: Hospitalized patients receiving artificial nutrition -
Exclusion Criteria: Patients on normal oral feeding.
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Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Prevalence of patients receiving artificial nutrition during their hospitalization.
Periodo de tiempo: Baseline evaluation was performed for all patients on the same day, which corresponded to a variable time from the beginning of hospitalization.
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Among the 578 hospitalized patients, 56 (9.7%; 30 males, 26 females), with a mean age of 67.1 ± 11.6 years, were receiving artificial nutrition (AN).
The modalities of AN administration were as follows: total parenteral nutrition (TPN) in 39 patients, enteral nutrition (EN) in 16 patients, and EN plus supplemental parenteral nutrition (SPN) in 1 patient.
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Baseline evaluation was performed for all patients on the same day, which corresponded to a variable time from the beginning of hospitalization.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Evaluation of the total amount of calories received
Periodo de tiempo: Baseline evaluation was performed for all patients on the same day, which corresponded to a variable time from the beginning of hospitalization.
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The total caloric intake received by each patient was calculated based on the characteristics of nutritional parenteral and enteral products and the duration of their infusion.
The appropriateness of the caloric intake was calculated using the most accurate prediction formula suggested for a specific body mass index (BMI) range.
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Baseline evaluation was performed for all patients on the same day, which corresponded to a variable time from the beginning of hospitalization.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Protein intake/kg of body weight
Periodo de tiempo: Baseline evaluation was performed for all patients on the same day, which corresponded to a variable time from the beginning of hospitalization.
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Patients admitted to the intensive care unit were fed by enteral nutrition and received only 0.41 ± 0.15 g/kg b.w.
Patients receiving parenteral nutrition had a protein intake ranging from 0.55 ± 0.15 to 0.70 ± 0.17 g/kg of body weight.
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Baseline evaluation was performed for all patients on the same day, which corresponded to a variable time from the beginning of hospitalization.
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The median time elapsed between hospital admission and the initiation of artificial nutrition (AN).
Periodo de tiempo: This evaluation was performed at baseline
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The median time to initiate AN following hospital admission was 3 days (IQR 0-13.5 days).
In detail, ICU patients received AN after 1 day (IQR 0-2), whereas patients in other wards received saline solutions with or without glucose for 5 days (IQR 0-16) after admission before commencing AN.
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This evaluation was performed at baseline
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Michele Barone, University of Bari
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Pirlich M, Schutz T, Norman K, Gastell S, Lubke HJ, Bischoff SC, Bolder U, Frieling T, Guldenzoph H, Hahn K, Jauch KW, Schindler K, Stein J, Volkert D, Weimann A, Werner H, Wolf C, Zurcher G, Bauer P, Lochs H. The German hospital malnutrition study. Clin Nutr. 2006 Aug;25(4):563-72. doi: 10.1016/j.clnu.2006.03.005. Epub 2006 May 15.
- Correia MI, Hegazi RA, Higashiguchi T, Michel JP, Reddy BR, Tappenden KA, Uyar M, Muscaritoli M. Evidence-based recommendations for addressing malnutrition in health care: an updated strategy from the feedM.E. Global Study Group. J Am Med Dir Assoc. 2014 Aug;15(8):544-50. doi: 10.1016/j.jamda.2014.05.011. Epub 2014 Jul 2.
- Singer P, Blaser AR, Berger MM, Alhazzani W, Calder PC, Casaer MP, Hiesmayr M, Mayer K, Montejo JC, Pichard C, Preiser JC, van Zanten ARH, Oczkowski S, Szczeklik W, Bischoff SC. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2019 Feb;38(1):48-79. doi: 10.1016/j.clnu.2018.08.037. Epub 2018 Sep 29.
- Jensen GL, Cederholm T, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, de Baptista GA, Barazzoni R, Blaauw R, Coats AJS, Crivelli A, Evans DC, Gramlich L, Fuchs-Tarlovsky V, Keller H, Llido L, Malone A, Mogensen KM, Morley JE, Muscaritoli M, Nyulasi I, Pirlich M, Pisprasert V, de van der Schueren M, Siltharm S, Singer P, Tappenden KA, Velasco N, Waitzberg DL, Yamwong P, Yu J, Compher C, Van Gossum A. GLIM Criteria for the Diagnosis of Malnutrition: A Consensus Report From the Global Clinical Nutrition Community. JPEN J Parenter Enteral Nutr. 2019 Jan;43(1):32-40. doi: 10.1002/jpen.1440. Epub 2018 Sep 2.
- Totland TH, Krogh HW, Smedshaug GB, Tornes RA, Bye A, Paur I. Harmonization and standardization of malnutrition screening for all adults - A systematic review initiated by the Norwegian Directorate of Health. Clin Nutr ESPEN. 2022 Dec;52:32-49. doi: 10.1016/j.clnesp.2022.09.028. Epub 2022 Oct 2.
- Amato V, De Caprio C, Santarpia L, De Rosa A, Bongiorno C, Stella G, De Rosa E, Iacone R, Scanzano C, Pasanisi F, Contaldo F. Time trend prevalence of artificial nutrition counselling in a university hospital. Nutrition. 2019 Feb;58:181-186. doi: 10.1016/j.nut.2018.08.014. Epub 2018 Aug 24.
- Krishnan S, Sytsma T, Wischmeyer PE. Addressing the Urgent Need for Clinical Nutrition Education in PostGraduate Medical Training: New Programs and Credentialing. Adv Nutr. 2024 Nov;15(11):100321. doi: 10.1016/j.advnut.2024.100321. Epub 2024 Oct 16.
- Wunderle C, Gomes F, Schuetz P, Stumpf F, Austin P, Ballesteros-Pomar MD, Cederholm T, Fletcher J, Laviano A, Norman K, Poulia KA, Schneider SM, Stanga Z, Bischoff SC. ESPEN practical guideline: Nutritional support for polymorbid medical inpatients. Clin Nutr. 2024 Mar;43(3):674-691. doi: 10.1016/j.clnu.2024.01.008. Epub 2024 Jan 24.
- Bolado Jimenez C, Fernadez Ovalle H, Munoz Moreno MF, Aller de la Fuente R, de Luis Roman DA. Undernutrition measured by the Mini Nutritional Assessment (MNA) test and related risk factors in older adults under hospital emergency care. Nutrition. 2019 Oct;66:142-146. doi: 10.1016/j.nut.2019.04.005. Epub 2019 May 10.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
10 de junio de 2024
Finalización primaria (Actual)
12 de junio de 2024
Finalización del estudio (Actual)
12 de junio de 2024
Fechas de registro del estudio
Enviado por primera vez
28 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
26 de mayo de 2026
Publicado por primera vez (Actual)
2 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
3 de junio de 2026
Última verificación
1 de junio de 2024
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Policlinico Bari 1698
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
The study was already completed, and all the data will be published.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .