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Frailty is a geriatric syndrome that primarily affects older patients, but also patients with severe illnesses. It is particularly common among oncology patients, but also among patients with gastrointestinal diseases such as liver cirrhosis or pancreatitis. Sarcopenia, a form of frailty, is defined as a loss of muscle quantity, quality and function. Currently, complex methods such as CT or bioimpedance measurement are available. However, simpler techniques such as ultrasound-based measurement could be alternatives, but still require further validation. In addition, serological muscle markers could support and simplify diagnostics.
The aim of this project is to be able to estimate the prognosis of patients at an early stage by measuring sarcopenia using ultrasound and biomarkers.
Frailty is a well-known syndrome that has a negative impact on many diseases and the course of disease. Patients affected by frailty are particularly vulnerable due to their inadequate ability to deal with extrinsic and intrinsic stressors. The prevalence of frailty increases with age, affecting 15% of people over the age of 65 and 25% of people over the age of 80.
Frailty is the end result of an interplay between malnutrition, cognitive impairment and muscle wasting. Each of these factors can be further examined and measured, but they also influence each other. In particular, reduced muscle mass and muscle function have been associated with poor quality of life and a worse course of disease. Sarcopenia is therefore becoming an increasingly important factor in various disease patterns and should be monitored further. Muscle atrophy and sarcopenia have multifactorial causes. Physical inactivity, chronic inflammation associated with chronic diseases, and malnutrition are particularly important in this context. Cross-sectional measurement of several muscles at the level of the lumbar vertebrae (L3), normalized to body size, and dual X-ray absorptiometry are currently the most commonly used techniques for measuring sarcopenia. However, complex equipment and procedures are required for the measurements. Furthermore, radiological imaging is costly and causes radiation exposure. Therefore, attempts have been made in the past to simplify the measurements. Sonographic measurement is a practical alternative. Many different muscle groups are accessible to ultrasound. In particular, the thigh muscles and the psoas major muscle can be easily visualized using sonography. The sonographic assessment of the psoas muscle area index (PMAI) and the thigh muscle thickness index (TMTI) are approaches to bedside morphometry that we use primarily.
Currently, little is known about serological muscle parameters. Measurement in the blood would be more elegant than sonographic muscle measurement. This would save additional instrumental diagnostics and still provide an impression of the musculature and thus possibly of the patient's fitness. Various biomarkers come into question for this. In particular, markers of muscle protein synthesis such as activin A/B and myostatin have already been described in individual collectives. However, biomarkers require further research, especially in various disease entities.
The investigators expect sonographic and laboratory measurements of the musculature to provide a better assessment of prognosis, quality of life and functional results during therapy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound | Diagnostic Test | Sonographisch measurement of muscles Blood muscle markers |
| Measure | Description | Time Frame |
|---|---|---|
| Complication | Number of patients with decompensation of the underlying disease (e.g. liver cirrhosis: hyropic decompensation) or hospitalisation or death | From the date of enrollment until the date of first documented complication (decopmensation, hospitalisation, death) from any cause whichever came first, assessed up to two years |
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Inclusion Criteria:
Exclusion Criteria:
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oncological patient in the field of gastrointestinal tumors patients with liver cirrhosis patients attending the intensive care unit
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wolfgang Maximilian Kremer Kremer, MD | Contact | 00496131175711 | maximilian.kremer@unimedizin-mainz.de | |
| Christian Labenz Labenz, MD | Contact | 0049 6131174209 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitatsmedizin Mainz | Recruiting | Mainz | Rhineland-Palatinate | 55131 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34775741 | Result | Lena A, Hadzibegovic S, von Haehling S, Springer J, Coats AJ, Anker MS. Sarcopenia and cachexia in chronic diseases: from mechanisms to treatment. Pol Arch Intern Med. 2021 Dec 22;131(12):16135. doi: 10.20452/pamw.16135. Epub 2021 Nov 15. | |
| 34881516 | Result | Kremer WM, Labenz C, Kuchen R, Sagoschen I, Bodenstein M, Schreiner O, Worns MA, Sivanathan V, Weinmann A, Galle PR, Sprinzl MF. Sonographic assessment of low muscle quantity identifies mortality risk during COVID-19: a prospective single-centre study. J Cachexia Sarcopenia Muscle. 2022 Feb;13(1):169-179. doi: 10.1002/jcsm.12862. Epub 2021 Dec 8. |
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We will make the data available accordingly in the context of publications.
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D009369 | Neoplasms |
| D002100 | Cachexia |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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EDTA 7,5 ml
| 31725030 | Result | Pinto Dos Santos D, Kloeckner R, Koch S, Hoppe-Lotichius M, Zoller D, Toenges G, Kremer WM, Zimmermann T, Mittler J, Lang H, Duber C, Galle PR, Weinmann A, Sprinzl MF. Sarcopenia as prognostic factor for survival after orthotopic liver transplantation. Eur J Gastroenterol Hepatol. 2020 May;32(5):626-634. doi: 10.1097/MEG.0000000000001552. |
| 35639492 | Result | Zhang JX, Yan HT, Ding Y, Liu J, Liu S, Zu QQ, Shi HB. Low Psoas-Muscle index is associated with decreased survival in hepatocellular carcinoma treated with transarterial chemoembolization. Ann Med. 2022 Dec;54(1):1562-1569. doi: 10.1080/07853890.2022.2081872. |
| 30587866 | Result | Hida T, Ando K, Kobayashi K, Ito K, Tsushima M, Kobayakawa T, Morozumi M, Tanaka S, Machino M, Ota K, Kanbara S, Ito S, Ishiguro N, Hasegawa Y, Imagama S. <Editors' Choice> Ultrasound measurement of thigh muscle thickness for assessment of sarcopenia. Nagoya J Med Sci. 2018 Nov;80(4):519-527. doi: 10.18999/nagjms.80.4.519. |
| 31547952 | Result | Hari A, Berzigotti A, Stabuc B, Caglevic N. Muscle psoas indices measured by ultrasound in cirrhosis - Preliminary evaluation of sarcopenia assessment and prediction of liver decompensation and mortality. Dig Liver Dis. 2019 Nov;51(11):1502-1507. doi: 10.1016/j.dld.2019.08.017. Epub 2019 Sep 20. |
| 28821966 | Result | Kobayashi K, Maruyama H, Kiyono S, Ogasawara S, Suzuki E, Ooka Y, Chiba T, Kato N, Yamaguchi T. Application of transcutaneous ultrasonography for the diagnosis of muscle mass loss in patients with liver cirrhosis. J Gastroenterol. 2018 May;53(5):652-659. doi: 10.1007/s00535-017-1378-2. Epub 2017 Aug 18. |
| 21448087 | Result | Takai Y, Katsumata Y, Kawakami Y, Kanehisa H, Fukunaga T. Ultrasound method for estimating the cross-sectional area of the psoas major muscle. Med Sci Sports Exerc. 2011 Oct;43(10):2000-4. doi: 10.1249/MSS.0b013e31821994cb. |
| 24737560 | Result | McLean RR, Shardell MD, Alley DE, Cawthon PM, Fragala MS, Harris TB, Kenny AM, Peters KW, Ferrucci L, Guralnik JM, Kritchevsky SB, Kiel DP, Vassileva MT, Xue QL, Perera S, Studenski SA, Dam TT. Criteria for clinically relevant weakness and low lean mass and their longitudinal association with incident mobility impairment and mortality: the foundation for the National Institutes of Health (FNIH) sarcopenia project. J Gerontol A Biol Sci Med Sci. 2014 May;69(5):576-83. doi: 10.1093/gerona/glu012. |
| 24737559 | Result | Cawthon PM, Peters KW, Shardell MD, McLean RR, Dam TT, Kenny AM, Fragala MS, Harris TB, Kiel DP, Guralnik JM, Ferrucci L, Kritchevsky SB, Vassileva MT, Studenski SA, Alley DE. Cutpoints for low appendicular lean mass that identify older adults with clinically significant weakness. J Gerontol A Biol Sci Med Sci. 2014 May;69(5):567-75. doi: 10.1093/gerona/glu023. |
| 31171417 | Result | Cruz-Jentoft AJ, Sayer AA. Sarcopenia. Lancet. 2019 Jun 29;393(10191):2636-2646. doi: 10.1016/S0140-6736(19)31138-9. Epub 2019 Jun 3. |
| 24607622 | Result | Durand F, Buyse S, Francoz C, Laouenan C, Bruno O, Belghiti J, Moreau R, Vilgrain V, Valla D. Prognostic value of muscle atrophy in cirrhosis using psoas muscle thickness on computed tomography. J Hepatol. 2014 Jun;60(6):1151-7. doi: 10.1016/j.jhep.2014.02.026. Epub 2014 Mar 6. |
| 31722892 | Result | Benz E, Trajanoska K, Lahousse L, Schoufour JD, Terzikhan N, De Roos E, de Jonge GB, Williams R, Franco OH, Brusselle G, Rivadeneira F. Sarcopenia in COPD: a systematic review and meta-analysis. Eur Respir Rev. 2019 Nov 13;28(154):190049. doi: 10.1183/16000617.0049-2019. Print 2019 Dec 31. |
| 26882087 | Result | Shachar SS, Williams GR, Muss HB, Nishijima TF. Prognostic value of sarcopenia in adults with solid tumours: A meta-analysis and systematic review. Eur J Cancer. 2016 Apr;57:58-67. doi: 10.1016/j.ejca.2015.12.030. Epub 2016 Feb 13. |
| 30312372 | Result | 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 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169. |
| 20392703 | Result | Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13. |
| 28095426 | Result | Beaudart C, Zaaria M, Pasleau F, Reginster JY, Bruyere O. Health Outcomes of Sarcopenia: A Systematic Review and Meta-Analysis. PLoS One. 2017 Jan 17;12(1):e0169548. doi: 10.1371/journal.pone.0169548. eCollection 2017. |
| 21093718 | Result | Xue QL. The frailty syndrome: definition and natural history. Clin Geriatr Med. 2011 Feb;27(1):1-15. doi: 10.1016/j.cger.2010.08.009. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013851 | Thinness |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |