Public trial
RBR-82p87rq Association of weakness and low muscle mass with clinical outcomes in hemodialysis patients: SARC-HD project
Date of registration: 02/07/2024 (mm/dd/yyyy)Last approval date : 02/07/2024 (mm/dd/yyyy)
Study type:
Observational
Scientific title:
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Sarcopenia and its association with clinical outcomes in Hemodialysis patients: SARC-HD project
pt-br
Sarcopenia e a sua associação com desfechos clínicos em pacientes em Hemodiálise: projeto SARC-HD
es
Sarcopenia and its association with clinical outcomes in Hemodialysis patients: SARC-HD project
Trial identification
- UTN code: U1111-1279-1302
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Public title:
en
Association of weakness and low muscle mass with clinical outcomes in hemodialysis patients: SARC-HD project
pt-br
Associação da fraqueza e pouca massa muscular com resultados clínicos em pacientes em hemodiálise
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Scientific acronym:
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Public acronym:
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Secondaries identifiers:
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57718722.8.1001.8118
Issuing authority: Plataforma Brasil
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5.418.365
Issuing authority: Comitê de Ética do Centro Universitário ICESP
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57718722.8.1001.8118
Sponsors
- Primary sponsor: Centro Universitário ICESP
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Secondary sponsor:
- Institution: Universidade de Brasília
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Supporting source:
- Institution: Fundação de Apoio à Pesquisa do Distrito Federal (FAPDF)
Health conditions
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Health conditions:
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Sarcopenia
pt-br
Sarcopenia
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General descriptors for health conditions:
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N18 Kidney failure
pt-br
N18 Insuficiência renal crônica
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Specific descriptors:
en
C10.597.613.612.500 Sarcopenia
pt-br
C10.597.613.612.500 Sarcopenia
Interventions
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Interventions:
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1008 patients with renal failure undergoing hemodialysis at several dialysis centers in Brazil will be evaluated for sarcopenia (low physical function and low muscle mass) and prospectively followed up for 12 months, where they will be re-evaluated for sarcopenia conditions. Subsequently, patients will be followed up again for another 12 months. In the follow-up periods, clinical outcomes such as falls, hospitalization and mortality will be monitored. The aim of the study is to longitudinally investigate the transitions of sarcopenia and their determinants. Furthermore, to investigate the association between operational diagnoses of sarcopenia and adverse clinical outcomes.
pt-br
1008 pacientes com falência renal em tratamento de hemodiálise em diversos centros de diálise no Brasil serão avaliados para a sarcopenia (baixa função física e baixa massa muscular) e, prospectivamente, acompanhados por 12 meses, onde serão reavaliados para as condições de sarcopenia. Posteriormente, os pacientes serão novamente acompanhados por mais 12 meses. Nos períodos de acompanhamentos, os desfechos clínicos quedas, hospitalização e mortalidade serão monitorados. O objetivo do estudo é investigar longitudinalmente as transições dos estágios da sarcopenia e seus determinantes. Ademais, investigar a associação entre os diagnósticos operacionais da sarcopenia com desfechos clínicos adversos.
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Descriptors:
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V03.175.500 Observational Study
pt-br
V03.175.500 Estudo Observacional
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E02.870.300 Renal dialysis
pt-br
E02.870.300 Diálise Renal
Recruitment
- Study status: Recruitment completed
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Countries
- Brazil
- Date first enrollment: 10/01/2022 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 1008 - 18 Y 0 -
Inclusion criteria:
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equal or older than 18 years; hemodialysis treatment for at least three months.
pt-br
maior ou igual a 18 anos; tratamento hemodialítico por pelo menos três meses
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Exclusion criteria:
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Inability or refusal to sign/provide the informed consent form; Any impairment that compromises participation in the study, such as cognitive impairment, locomotor and/or neurological disorders; Change of renal replacement therapy or clinical center (non-partner) during the data collection phase, in a previously planned way, or during the follow-up; Medical contraindication for carrying out the battery of physical tests; Permanent pacemaker (contraindication to bioimpedance measurement); Uncontrolled heart disease, cardiovascular surgery, or recent hospitalization (one month before baseline).
pt-br
Incapacidade ou recusa de assinar/fornecer o termo de consentimento livre e esclarecido; possuir qualquer acometimento que comprometa a participação no estudo, tais como distúrbios do aparelho locomotor e/ou neurológica; contraindicação médica para realização da bateria de testes físicos; cardiopatias não controladas, cirurgia cardiovascular ou hospitalização recente (um mês).
Study type
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Study design:
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Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase
Outcomes
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Primary outcomes:
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We expect to find out the determinants of the transitions between sarcopenia stages (pre-sarcopenia, sarcopenia, and confirmed sarcopenia), assessed according to the revised European Working Group on Sarcopenia in Older People consensus (muscle strength, muscle mass, and physical performance).
pt-br
Esperamos descobrir os determinantes das transições entre os estágios da sarcopenia (pré-sarcopenia, sarcopenia e sarcopenia confirmada), avaliados de acordo com o consenso revisado do European Working Group on Sarcopenia in Older People (força muscular, massa muscular e performance física).
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Secondary outcomes:
en
We expect to verify an association of sarcopenia traits, assessed by muscle strength, muscle mass, and physical performance, with clinical outcomes (i.e., falls, hospitalization, and mortality) assessed by medical records.
pt-br
Esperamos verificar uma associação dos traços de sarcopenia, avaliados pela força muscular, massa muscular e desempenho físico, com os desfechos clínicos (i.e., quedas, hospitalização e mortalidade) avaliados pelos prontuários.
Contacts
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Public contact
- Full name: Heitor Siqueira Ribeiro
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- Address: QS 05 Rua 300 Lote 01, Águas Claras, Núcleo Interdisciplinar de Pesquisa
- City: Brasília / Brazil
- Zip code: 71.961-540
- Phone: +55(61)30359500
- Email: heitor.ribeiro@icesp.edu.br
- Affiliation: Centro Universitário ICESP
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Scientific contact
- Full name: Maycon de Moura Reboredo
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- Address: Campus Universitário, Faculdade de Medicina, Rua José Lourenço Kelmer, s/n - São Pedro
- City: Juiz de Fora / Brazil
- Zip code: 36036-900
- Phone: +55(32)2102-3841
- Email: maycon.reboredo@ufjf.br
- Affiliation: Universidade Federal de Juiz de Fora
- Full name: Marvery Peterson Duarte
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- Address: UnB - Faculdade de Ciências de Saúde - Asa Norte
- City: Brasília / Brazil
- Zip code: 70910-900
- Phone: +55(61)31071940
- Email: duarte.marvery@aluno.unb.br
- Affiliation: Universidade de Brasília
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Site contact
- Full name: Centro Universitário ICESP
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- Address: QS 05 Rua 300 Lote 01, Núcleo Interdisciplinar de Pesquisa, Águas Claras
- City: Brasília / Brazil
- Zip code: 71.961-540
- Phone: +55(61)30359500
- Email: cep@icesp.edu.br
- Affiliation: Centro Universitário ICESP
Additional links:
Total de Ensaios Clínicos 16961.
Existem 8355 ensaios clínicos registrados.
Existem 4701 ensaios clínicos recrutando.
Existem 241 ensaios clínicos em análise.
Existem 5772 ensaios clínicos em rascunho.