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Идёт набор NCT04502719

Comparison of Nutritional Screening Tools in Liver Cirrhosis Patients

Наблюдательное Malnutrition Cirrhosis, Liver

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Nutritional screening..
Кому может быть актуально
Состояния в реестре: Malnutrition, Cirrhosis, Liver. Базовые параметры: 18 лет — 100 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Comparison of Two Nutritional Screening Tools for the Detection of Malnutrition in Patients with Liver Cirrhosis

Обзор

This study compares two nutritional screening questionnaires in cirrhotic patients. All patients will be assessed with both questionnaires, besides a complete nutritional assessment.

Подробное описание

Disease-related malnutrition is a health problem with high prevalence and associated costs. Poor nutritional status has an unfavorable effect on clinical outcomes in terms of complications, post-transplant survival and mortality in relation to the liver, in addition to a decrease in quality of life. The same complications of liver disease, such as hypoalbuminemia or ascites, make it difficult to assess malnutrition in cirrhotic patients.

The use of screening tools defines the first step in the prevention and treatment of patients at risk of malnutrition or overt malnutrition. The use of screening tools to detect malnutrition upon admission to hospital improves the identification of malnourished patients by 50-80%, early treatment of patients can reduce hospital stay. It has been observed that nutritional interventions, after assessment of nutritional risk, appear to prevent complications and improve quality of life and survival rate in cirrhotic patients.

Due to changes in body composition in cirrhotic patients (i.e. ascites), the most common questionnaires for screening for malnutrition (e.g. MUST, NRS-2002), which use anthropometric measures, have not been validated in cirrhosis and are therefore not considered suitable for malnutrition screening. On the contrary, in recent years two specific nutritional screening tools have been developed for cirrhotic patients, the Royal Free Hospital Nutritional Prioritizing Tool (RFH-NPT) and the Liver Disease Undernutrition Screening Tool (LDUST). Both questionnaires, however, require further validation against clinical outcomes in cirrhotic patients.

This study will use two screening tools for malnutrition risk (RFH-NPT and LDUST), to compare their validity in detecting malnutrition risk in patients with liver cirrhosis. These tools will be validated by performing a nutritional assessment with the new diagnostic criteria of malnutrition promoted by the Global Leadership Initiative on Malnutrition.

Sarcopenia can occur in malnourished cirrhotic patients, so it will be of interest to know what the possible prevalence may be in the sample of patients studied. The use of the screening questionnaire SARC-F will allow an assessment of the prevalence of risk of sarcopenia. Situations such as malnutrition or sarcopenia can have an impact on the patient's health-related quality of life, so this parameter will be assessed using the Chronic Liver Disease Questionnaire.

Вмешательства

  • Диагностический тест Nutritional screening.
    Nutritional screening with the RFH-NPT and LDUST questionnaires.

Первичные конечные точки

  • Malnutrition diagnostic concordance. [Срок оценки: 48 hours]
Вторичные конечные точки (4)
  • Malnutrition prevalence. [Срок оценки: 48 hours.]
  • Sarcopenia prevalence. [Срок оценки: 48 hours.]
  • Quality of life score. [Срок оценки: 48 hours.]
  • Adverse clinical outcomes. [Срок оценки: 6 months.]

Критерии участия

Критерии включения

  • Patients diagnosed with liver cirrhosis.

Критерии исключения

  • Patients with cognitive impairment or major psychiatric disorder.
  • Lack of consent from the patient for inclusion in the study.
  • Any patient who is not suitable based on the researcher's own judgement.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Испания · 1 центр
  • Hospital Clinic de Barcelona — Barcelona

Публикации

  • Ferreira LG, Anastacio LR, Lima AS, Touslon Davisson Correia MI. Predictors of mortality in patients on the waiting list for liver transplantation. Nutr Hosp. 2013 May-Jun;28(3):914-9. doi: 10.3305/nh.2013.28.3.6333. PMID 23848119
  • Iwasa M, Iwata K, Hara N, Hattori A, Ishidome M, Sekoguchi-Fujikawa N, Mifuji-Moroka R, Sugimoto R, Fujita N, Kobayashi Y, Takei Y. Nutrition therapy using a multidisciplinary team improves survival rates in patients with liver cirrhosis. Nutrition. 2013 Nov-Dec;29(11-12):1418-21. doi: 10.1016/j.nut.2013.05.016. PMID 24103520
  • Tandon P, Raman M, Mourtzakis M, Merli M. A practical approach to nutritional screening and assessment in cirrhosis. Hepatology. 2017 Mar;65(3):1044-1057. doi: 10.1002/hep.29003. Epub 2017 Feb 6. PMID 28027577
  • Cederholm T, Jensen GL, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, Baptista G, Barazzoni R, Blaauw R, Coats A, 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 MAE, Siltharm S, Singer P, Tappenden K, Velasco N, Waitzberg D, Yamwong P, Yu J, Van Gossum A, Comp PMID 30181091

Идентификаторы

NCT: NCT04502719 · NUSCIR-20

Первоисточники (государственные реестры)

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