Public trial
RBR-10jksk74 Evaluation of biomarkers and gene expression profile related to peripheral microvascular reserve in patients with severe...
Date of registration: 01/28/2022 (mm/dd/yyyy)Last approval date : 01/28/2022 (mm/dd/yyyy)
Study type:
Observational
Scientific title:
en
Evaluation of biomarkers and gene expression profile related to peripheral microvascular reserve in septic patients
pt-br
Avaliação de biomarcadores e perfil de expressão gênica relacionados à reserva microvascular periférica de pacientes com sepse
es
Evaluation of biomarkers and gene expression profile related to peripheral microvascular reserve in septic patients
Trial identification
- UTN code: U1111-1273-4221
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Public title:
en
Evaluation of biomarkers and gene expression profile related to peripheral microvascular reserve in patients with severe infections
pt-br
Avaliação de biomarcadores e perfil de expressão gênica relacionados à reserva microvascular periférica de pacientes com infecções graves
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Scientific acronym:
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Public acronym:
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Secondaries identifiers:
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5.181.160
Issuing authority: Comitê de Ética em Pesquisa do Hospital de Clínicas da Universidade Federal do Paraná
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28824120.3.0000.0096
Issuing authority: Plataforma Brasil
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5.181.160
Sponsors
- Primary sponsor: Hospital de Clínicas - Universidade Federal do paraná
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Secondary sponsor:
- Institution: Instituto Carlos Chagas - Fiocruz
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Supporting source:
- Institution: Instituto Carlos Chagas - Fiocruz
Health conditions
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Health conditions:
en
sepsis; biomarkers; gene expression; prognosis
pt-br
sepse; biomarcadores; expressão gênica; prognóstico
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General descriptors for health conditions:
en
D011379 PROGNOSIS
pt-br
D011379 PROGNÓSTICO
en
A41.9 sepsis
pt-br
A41.9 sepse
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Specific descriptors:
en
C23.550.470.790.500 sepse
pt-br
C23.550.470.790.500 sepsis
en
D23.101 biomarkers
pt-br
D23.101 biomarcadores
en
G05.297 gene expression
pt-br
G05.297 expressão gênica
Interventions
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Interventions:
en
Blood samples will be collected for RNA extraction (total of 5 ml) from 168 consecutive patients admitted for sepsis to the Intensive Care Unit
pt-br
Serão coletadas amostras de sangue para extração do RNA (total de 5 ml) de 168 pacientes consecutivos admitidos por sepse na Unidade de Terapia Intensiva
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Descriptors:
en
D005796 Genes
pt-br
D005796 Genes
Recruitment
- Study status: Recruiting
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Countries
- Brazil
- Date first enrollment: 10/01/2021 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 168 - 18 Y 0 -
Inclusion criteria:
en
Adult patients; age above 18 years; diagnosed with sepsis; admitted to the Intensive Care Units
pt-br
Pacientes adultos; idade acima de 18 anos; com diagnóstico de sepse; internados nas Unidades de Terapia Intensivas
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Exclusion criteria:
en
Pregnancy; refusal to participate in the study; exclusion of the sepsis diagnosis after data collection; diagnosis of acute SARS-COV2 (COVID-19) infection
pt-br
Gravidez; recusa do paciente a participar do estudo; exclusão do diagnóstico de sepse posteriormente à coleta dos dados; diagnóstico de infecção aguda por SARS-COV2 (COVID-19)
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:
en
In-hospital mortality rate, with 28-day survival curve, among septic patients with the MARS-1 genomic endotype, with the expectation that this endotype presents a mortality risk up to 2 times higher in this population
pt-br
Taxa de mortalidade intra-hospitalar, com curva de sobrevida em 28 dias, entre pacientes sépticos com o endotipo genômico MARS-1, com expectativa de que este endotipo apresente um risco de mortalidade até 2 vezes maior nesta população
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Secondary outcomes:
en
In-hospital 28-day mortality rate of other genomic endotypes (MARS 2,3,4) among septic patients in Brazil
pt-br
Taxa de mortalidade intra-hospitalar em 28 dias dos demais endotipos genômicos (MARS 2,3,4) entre os pacientes sépticos no Brasil
en
Correlation analysis between the four genomic endotypes and clinical, hemodynamic and protein markers variables
pt-br
Análise de correlação entre os quatro endotipos genômicos e variáveis clínicas, hemodinâmicas e marcadores protéicos
Contacts
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Public contact
- Full name: Fernanda do Carmo De Stefani
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- Address:
- City: / Brazil
- Zip code:
- Phone: +55(41)999821324
- Email: fe_destefani@yahoo.com
- Affiliation:
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Scientific contact
- Full name: Fernanda do Carmo De Stefani
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- Address:
- City: / Brazil
- Zip code:
- Phone: +55(41)999821324
- Email: fe_destefani@yahoo.com
- Affiliation:
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Site contact
- Full name: Fernanda do Carmo De Stefani
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- Address:
- City: / Brazil
- Zip code:
- Phone: +55(41)999821324
- Email: fe_destefani@yahoo.com
- Affiliation:
Additional links:
Total de Ensaios Clínicos 16962.
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