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Идёт набор NCT04791540

Sarcopenia and Nutritional Status in a Rehabilitation Setting

— Наблюдательное Sarcopenia

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: handgrip strenght, Bioelectrical Impedance Analysis (BIA), MUST, GLIM.
Кому может быть актуально
Состояния в реестре: Sarcopenia. Базовые параметры: от 18 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
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Observational Pilot Study in Patients Who Underwent Tracheostomy: Sarcopenia Assessment by Handgrip Strenght and BIA. Association to Malnutrion Risk, Nutritional Status, Gut Microbioma and Decannulation Time.

Обзор

In this pilot observational study the primary outcome is to assess, in a Respiratory Rehabilitation Unit, if there is an association between sarcopenia, assessed by handgrip strenght and BIA, and a delayed decannulation time in patients who underwent tracheostomy. Secondary outcomes are to assess if there is an association between an increased malnutrition risk (assessed by MUST), a poor nutritional status (assessed by GLIM criteria) and a delayed decannulation time and the gut microbiota composition.

Вмешательства

  • Диагностический тест handgrip strenght
    Muscle strenght measured with a handheld dynamometer, at admission (T0) and at decannulation time (T1)
  • Диагностический тест Bioelectrical Impedance Analysis (BIA)
    Muscle mass evaluated by Bioelectrical Impedance Analysis (BIA), at admission (T0) and at decannulation time (T1)
  • Диагностический тест MUST
    Malnutrition risk assessed by Malnutrition Universal Screening Tool (MUST), at admission (T0) and at decannulation time (T1)
  • Диагностический тест GLIM
    Malnutrition diagnosis performed by Global Leadership Initiative on Malnutrition (GLIM) criteria, at admission (T0) and at decannulation time (T1)
  • Биопрепарат Gut microbiota
    A fecal sample obtained at admission (T0) and at decannulation time (T1)
  • Биопрепарат Blood Sample
    A Blood sample obtained at admission (T0) and at decannulation time (T1)
  • Другое Anthropometric measures
    Measurement of weight and height (assessed only at admission) to calculate the Body Mass Index (BMI), at admission (T0) and at decannulation time (T1)

Первичные конечные точки

  • Change from admission in muscle mass at decannulation time [Срок оценки: Respiratory Rehabilitation Unit admission (T0) and decannulation time (T1), an average of 10 days]
  • Change from admission in hangrip strenght at decannulation time [Срок оценки: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days]
Вторичные конечные точки (12)
  • Change from admission in Body Mass Index (BMI) score at decannulation time [Срок оценки: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days]
  • Change from admission in Malnutrition Universal Screening Tool (MUST) score at decannulation time [Срок оценки: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days]
  • Change from admission in nutritional status at decannulation time [Срок оценки: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days]
  • Change from admission in Gut Microbiota (GM) composition at decannulation time [Срок оценки: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days]
  • Protein C reactive (PCR) [Срок оценки: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days]
  • Lymphocyte count [Срок оценки: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days]
  • Creatinine [Срок оценки: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days]
  • Creatine Poshokinase [Срок оценки: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days]
  • Total serum protein [Срок оценки: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days]
  • Albumin [Срок оценки: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days]
  • Vitamin (25OH) D [Срок оценки: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days]
  • Selenium [Срок оценки: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days]

Критерии участия

Критерии включения

  • Signed informed consent from patients or legal guardians for patients unfit to plead
  • Presence of tracheostomy at admission

Критерии исключения

  • Refusal
  • Pregnancy
  • Pace maker/implantable cardioverter
  • No legal guardians for patients unfit to plead

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • Fondazione Don Carlo Gnocchi — Florence

Публикации

  • Cederholm T, Jensen GL, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, Baptista G, Barazzoni R, Blaauw R, Coats AJS, Crivelli AN, 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, C PMID 30920778
  • Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jul 1;48( PMID 31081853
  • Kyle UG, Bosaeus I, De Lorenzo AD, Deurenberg P, Elia M, Manuel Gomez J, Lilienthal Heitmann B, Kent-Smith L, Melchior JC, Pirlich M, Scharfetter H, M W J Schols A, Pichard C; ESPEN. Bioelectrical impedance analysis-part II: utilization in clinical practice. Clin Nutr. 2004 Dec;23(6):1430-53. doi: 10.1016/j.clnu.2004.09.012. PMID 15556267
  • Kutsukutsa J, Mashamba-Thompson TP, Saman Y. Tracheostomy decannulation methods and procedures in adults: a systematic scoping review protocol. Syst Rev. 2017 Dec 4;6(1):239. doi: 10.1186/s13643-017-0634-0. PMID 29202866
  • Ticinesi A, Nouvenne A, Cerundolo N, Catania P, Prati B, Tana C, Meschi T. Gut Microbiota, Muscle Mass and Function in Aging: A Focus on Physical Frailty and Sarcopenia. Nutrients. 2019 Jul 17;11(7):1633. doi: 10.3390/nu11071633. PMID 31319564
  • Toptas M, Yalcin M, Akkoc I, Demir E, Metin C, Savas Y, Kalyoncuoglu M, Can MM. The Relation between Sarcopenia and Mortality in Patients at Intensive Care Unit. Biomed Res Int. 2018 Feb 12;2018:5263208. doi: 10.1155/2018/5263208. eCollection 2018. PMID 29789798
  • Prado CM, Purcell SA, Alish C, Pereira SL, Deutz NE, Heyland DK, Goodpaster BH, Tappenden KA, Heymsfield SB. Implications of low muscle mass across the continuum of care: a narrative review. Ann Med. 2018 Dec;50(8):675-693. doi: 10.1080/07853890.2018.1511918. Epub 2018 Sep 12. PMID 30169116

Идентификаторы

NCT: NCT04791540 · SARCOBIA1_FDG

Первоисточники (государственные реестры)

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