Muscle Mass Via UltraSound in Cirrhosis (MMUSCLE)

Официальное название

Prospective Observational Cohort Survey to Assess the Prevalence and Development of Sarcopenia and the Correlation of Muscle Mass and Outcome in Patients With Cirrhosis by Skeletal Muscle Ultrasound.

Обзор

The goal of this observational cohort study is to learn about loss of muscle mass and muscle strength (sarcopenia) in patients with cirrhosis. The main question\[s\] it aims to answer are: * what is the prevalence and development of sarcopenia in cirrhosis? * what is the role of malnutrition? Participants will * undergo a muscle ultrasound of the lower and upper limb muscles * handgrip strength will be measured * malnutrition screening and assessment * complete a questionnaire to assess quality of life

Подробное описание

In this study, the investigators will assess the prevalence and development of sarcopenia in the large in- and outpatient population with cirrhosis (n= 1346) of the University Hospital of Antwerp, using ultrasound assessment of muscle mass and quality in the lower as well as the upper limb muscles. Handgrip strength will be tested for muscle functional status. Findings will be correlated with clinical outcome (MELD, survival, decompensating events). The etiology of the cirrhosis and its underlying activity will be taken into account as dependent variables, e.g. whether there is a difference between compensated vs. decompensated cirrhosis. The investigators will screen for malnutrition using the RFH-NPT and compare with the GLIM criteria. The effect of sarcopenia on the quality of life will be evaluated using the validated "SarQoL®" (Sarcopenia Quality of Life) questionnaire.

Вмешательства

• Другое ultrasound
  Ultrasound of m. quadriceps and m. thenar All ultrasound measurements will be performed in triplicate, with the average of the scores used in final analyses. Four parameters will be evaluated: muscle thickness, muscle cross sectional area, pennation angle and echo intensity (gain, depth and frequency will be kept constant). Hand grip strength measurement: measurement by an electronic hand dynamometer DynEx1TM (MD Systems, Inc. Ohio, USA). The recommendations for the handgrip strength test of th

Первичные конечные точки

• Prevalence of sarcopenia: muscle mass [Срок оценки: baseline]
• Prevalence of sarcopenia: muscle strength [Срок оценки: baseline]
• Development of sarcopenia: changes in muscle mass [Срок оценки: 2 years]
• Development of sarcopenia: changes in muscle strength [Срок оценки: 2 years]
• Development of sarcopenia: changes in muscle quality [Срок оценки: 2 years]

Вторичные конечные точки (5)

• Decompensation events: MELD score • MELD evolution [Срок оценки: 2 years]
• Decompensation events: mortality • MELD evolution [Срок оценки: 2 years]
• Decompensation events: transplantation • MELD evolution [Срок оценки: 2 years]
• Malnutrition [Срок оценки: 2 years]
• Quality of life in cirrhosis [Срок оценки: 2 years]

Критерии участия

Критерии включения

• diagnosis of cirrhosis and follow-up in the University Hospital of Antwerp

Критерии исключения

• known patient will against participation in the study or against the measures applied in the study
• a decision made prior to inclusion to stop further treatment of the patient within the next 24 hours
• no complete remission of malignancy including hepatocellular carcinoma within the past 12 months

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Бельгия · 1 центр

• University Hospital Antwerp — Edegem

Публикации

• Dhaliwal A, Armstrong MJ. Sarcopenia in cirrhosis: A practical overview. Clin Med (Lond). 2020 Sep;20(5):489-492. doi: 10.7861/clinmed.2020-0089. PMID 32934043
• Lai JC, Tandon P, Bernal W, Tapper EB, Ekong U, Dasarathy S, Carey EJ. Malnutrition, Frailty, and Sarcopenia in Patients With Cirrhosis: 2021 Practice Guidance by the American Association for the Study of Liver Diseases. Hepatology. 2021 Sep;74(3):1611-1644. doi: 10.1002/hep.32049. No abstract available. PMID 34233031
• 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
• Hsu CS, Kao JH. Sarcopenia and chronic liver diseases. Expert Rev Gastroenterol Hepatol. 2018 Dec;12(12):1229-1244. doi: 10.1080/17474124.2018.1534586. Epub 2018 Oct 16. PMID 30791794
• Carey EJ, Lai JC, Sonnenday C, Tapper EB, Tandon P, Duarte-Rojo A, Dunn MA, Tsien C, Kallwitz ER, Ng V, Dasarathy S, Kappus M, Bashir MR, Montano-Loza AJ. A North American Expert Opinion Statement on Sarcopenia in Liver Transplantation. Hepatology. 2019 Nov;70(5):1816-1829. doi: 10.1002/hep.30828. Epub 2019 Aug 19. PMID 31220351
• Tandon P, Low G, Mourtzakis M, Zenith L, Myers RP, Abraldes JG, Shaheen AA, Qamar H, Mansoor N, Carbonneau M, Ismond K, Mann S, Alaboudy A, Ma M. A Model to Identify Sarcopenia in Patients With Cirrhosis. Clin Gastroenterol Hepatol. 2016 Oct;14(10):1473-1480.e3. doi: 10.1016/j.cgh.2016.04.040. Epub 2016 May 14. PMID 27189915
• Watanabe Y, Yamada Y, Fukumoto Y, Ishihara T, Yokoyama K, Yoshida T, Miyake M, Yamagata E, Kimura M. Echo intensity obtained from ultrasonography images reflecting muscle strength in elderly men. Clin Interv Aging. 2013;8:993-8. doi: 10.2147/CIA.S47263. Epub 2013 Jul 25. PMID 23926426
• Perkisas S, Baudry S, Bauer J, Beckwee D, De Cock AM, Hobbelen H, Jager-Wittenaar H, Kasiukiewicz A, Landi F, Marco E, Merello A, Piotrowicz K, Sanchez E, Sanchez-Rodriguez D, Scafoglieri A, Cruz-Jentoft A, Vandewoude M. Application of ultrasound for muscle assessment in sarcopenia: towards standardized measurements. Eur Geriatr Med. 2018 Dec;9(6):739-757. doi: 10.1007/s41999-018-0104-9. Epub 2018 PMID 34674473

Идентификаторы

NCT: NCT06345547 · EDGE 003539

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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