- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00698048
Serial Vasopressin and Copeptin Levels in Children With Sepsis and Septic Shock (VaCoSS)
Patients with severe infection can develop very low blood pressure. There are many mechanisms leading to this, and one of them appears to involve a hormone called vasopressin. In children as compared to adults, the mechanism and response to low blood pressure are different for reasons that are not clear. One possibility is the difference in the production and/or response to vasopressin. Vasopressin has become part of the treatment of children with low blood pressure in the setting of severe infection, when other treatment has failed, but its use is on the basis of animal and adult studies. The exact timing and dose is uncertain.
In this research study, the patients will receive standard treatment for sepsis and septic shock, and the investigators will measure the blood levels of vasopressin and a related compound called copeptin (both are required to understand the mechanism of control involved). Blood will need to be taken from patients without any sepsis so as to be able to compare the values in health and in sickness. The patient groups the investigators have chosen for this are those children who will have blood taken anyway as part of their routine care. The aim of this study is to develop an understanding of the body's hormonal response (with respect to vasopressin) to severe infection in children. The long-term aim is to improve the care of critically ill children with severe infection by using the most appropriate dose of vasopressin at the most appropriate time.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Singapore, Cingapura, 229899
- KK Women's and Children's Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
Control Group:
- Neonates admitted for neonatal jaundice requiring phototherapy
- Previously well patients admitted for elective gastrointestinal endoscopy, patients admitted for non-specific abdominal pain and
- Pre-operative patients for circumcision, inguinal hernias and chronic orthopaedic conditions
Study Group:
- The investigators will also enroll children with sepsis and septic shock
- Sepsis will be defined as proposed by the International pediatric sepsis consensus conference.
- Children will be recruited into the septic shock group if they have sepsis and features of cardiovascular organ dysfunction as defined by the same consensus conference.
Exclusion Criteria:
- Neonates weighing less than 2.5 kg
- Neonates less than 36 weeks gestation
- Children more than 16 years of age
- Patients with a history of congenital heart disease
- Patients with chronic renal impairment
- Patients with chronic liver impairment
- Patients on active chemotherapy
- Patients on chronic mineralocorticoids or glucocorticoids therapy
- Patients on long-term diuretic therapy
- Patients with central nervous system tumours
- Patients with developmental delay
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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1
Controles
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2
Sepsis
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3
Septic Shock
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Vasopressin and copeptin levels
Prazo: First 5 days of admission
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First 5 days of admission
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jan Hau Lee, MRCPCH(UK), KK Women's and Children's Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NIG07nov002
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