Sarco-COVID Study: Measuring the Loss of Skeletal Muscle Mass in the Hospitalized Patient With the Diagnosis of COVID-19
NCT ID: NCT04780126
Last Updated: 2021-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
64 participants
OBSERVATIONAL
2021-02-26
2021-05-31
Brief Summary
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Sarcopenia is present in 5-13% of people between 60 and 70 years old and in 11-50% of the population over 80 years of age. The diagnosis of sarcopenia has advanced in recent years by establishing homogeneous criteria in different consensuses that necessarily combine two elements: generalized loss of strength accompanied by loss of skeletal muscle mass. Today there are three consensuses for the diagnosis of sarcopenia: the international (IWGS), the European (EWGSOP), and the most recent from a US cohort (FNIH). In all of them, the measurement of skeletal muscle mass constitutes one of the two diagnostic criteria.
The main methods to measure this muscle loss that are established are imaging techniques (computerized tomography (CT), magnetic resonance imaging (MRI), dual-energy X-ray absorptiometry (DEXA) and ultrasound.
The most common ultrasound measurements used for this purpose are the muscle thickness (cm) at the point of the ultrasound path of maximum muscle thickness, the cross-sectional area (area calculated by the basic software at the point of maximum muscle thickness), and the pennation angle (angle formed between deep muscle fascia and muscle fibers). The first two measurements can be made on several long muscles, while the pennation angle is usually made primarily on the medial gastrocnemius (internal twin) muscle. They are easy to obtain, bloodless, and reproducible measurements.
Research efforts at this point in the pandemic should focus on the longer-term consequences of the disease, sequelae such as sarcopenia in patients who have suffered from COVID-19. At the same time, clinicians must become increasingly aware of the condition and its measurement integrated into clinical practice. The knowledge provided by studies such as the one presented will allow the development of specific interventions.
The risk of sarcopenia should be considered when carrying out a risk / benefit assessment of the established treatment (for example, dexamethasone), and considering a multidisciplinary treatment that includes dietary inputs.
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Detailed Description
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Conditions
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Study Design
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ECOLOGIC_OR_COMMUNITY
PROSPECTIVE
Study Groups
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COVID-19 pneumonia patients
Patients over 18 years of age who are admitted to the hospital and whose main diagnosis and reason for staying is COVID-19 pneumonia will be included.
Sarcopenia diagnosis
History, physical, laboratory and ultrasound parameters to diagnose sarcopenia
Interventions
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Sarcopenia diagnosis
History, physical, laboratory and ultrasound parameters to diagnose sarcopenia
Eligibility Criteria
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Inclusion Criteria
* Main diagnosis is pneumonia due to COVID-19
* Subjects who, after having received information about the design, the purposes of the project, the possible risks that may arise from it and who at any time may deny their collaboration, verbally grant their consent to participate in the study.
Exclusion Criteria
* Present a malignant neoplasm in active phase except spino- or basal cell Ca in local stage
* Clinical situation of agony.
* Amputation of limb (s).
18 Years
ALL
No
Sponsors
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Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
OTHER
Responsible Party
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Yale Tung Chen
Principal Investigator
Principal Investigators
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Yale Tung Chen, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Puerta de Hierro
Locations
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Hospital de Emergencias Isabel Zendal
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Yale Tung Chen, MD
Role: primary
References
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Epidemiologic and methodologic problems in determining nutritional status of older persons. Proceedings of a conference. Albuquerque, New Mexico, October 19-21, 1988. Am J Clin Nutr. 1989 Nov;50(5 Suppl):1121-235. No abstract available.
von Haehling S, Morley JE, Anker SD. An overview of sarcopenia: facts and numbers on prevalence and clinical impact. J Cachexia Sarcopenia Muscle. 2010 Dec;1(2):129-133. doi: 10.1007/s13539-010-0014-2. Epub 2010 Dec 17.
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.
Fielding RA, Vellas B, Evans WJ, Bhasin S, Morley JE, Newman AB, Abellan van Kan G, Andrieu S, Bauer J, Breuille D, Cederholm T, Chandler J, De Meynard C, Donini L, Harris T, Kannt A, Keime Guibert F, Onder G, Papanicolaou D, Rolland Y, Rooks D, Sieber C, Souhami E, Verlaan S, Zamboni M. Sarcopenia: an undiagnosed condition in older adults. Current consensus definition: prevalence, etiology, and consequences. International working group on sarcopenia. J Am Med Dir Assoc. 2011 May;12(4):249-56. doi: 10.1016/j.jamda.2011.01.003. Epub 2011 Mar 4.
Studenski SA, Peters KW, Alley DE, Cawthon PM, McLean RR, Harris TB, Ferrucci L, Guralnik JM, Fragala MS, Kenny AM, Kiel DP, Kritchevsky SB, Shardell MD, Dam TT, Vassileva MT. The FNIH sarcopenia project: rationale, study description, conference recommendations, and final estimates. J Gerontol A Biol Sci Med Sci. 2014 May;69(5):547-58. doi: 10.1093/gerona/glu010.
Nijholt W, Scafoglieri A, Jager-Wittenaar H, Hobbelen JSM, van der Schans CP. The reliability and validity of ultrasound to quantify muscles in older adults: a systematic review. J Cachexia Sarcopenia Muscle. 2017 Oct;8(5):702-712. doi: 10.1002/jcsm.12210. Epub 2017 Jul 12.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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21/090-E_COVID
Identifier Type: -
Identifier Source: org_study_id
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