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- Ensaio Clínico NCT02571920
Hemodynamic Monitoring, Positive Inotropic and Vasoactive Drugs During Cardiac Surgery (EMOA) (EMOA)
Hemodynamic Monitoring, Positive Inotropic and Vasoactive Drugs During Cardiac Surgery (EMOA Study)
Visão geral do estudo
Status
Condições
Descrição detalhada
The perioperative management in cardiac surgery patients has changed dramatically in the last fifteen years with the development of new cardiac output monitoring devices, the availability of new inotropic molecules, and a modern treatment for cardio-circulatory failure.
However, few studies report the possible changes in practice. The last French national survey was conducted in 2001. Since then, the literature is poor on the subject, and the impact of new approaches has been only marginally addressed. Recently, a German postal survey was conducted among cardiac surgery anesthesiologists, but on purely declarative elements and without patient data.
The investigators offer a type of national prospective observational study to evaluate professional practices, morbidity and mortality in cardiac surgical patients. This study must include all patients undergoing cardiac surgery at the participating centers during 7 weeks.
The main objective of this work is to assess the proportion of patients undergoing cardiac surgery receiving a cardiac output monitoring.
Secondary objectives are to describe the relationship between the use of cardiac output monitoring and the use of positive inotropic agents and vasoactive (type molecules, duration), volume expansion and transfusions the first 24 hours, and the incidence postoperative complications for patients undergoing cardiac surgery.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Caen, França
- Caen University 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:
- Patients over 18 years old undergoing cardiac surgery during the study period
Non-inclusion Criteria:
- age under 18 years old
- Extracorporeal life support and others cardiac assistance
- congenital cardiac surgery
- TAVI procedures
- Pericardium surgical drainages
- Sternal sepsis surgery
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Proportion of patients undergoing cardiac surgery and receiving a cardiac output monitoring.
Prazo: Up to 28 days after surgery (length of intensive care unit stay)
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Up to 28 days after surgery (length of intensive care unit stay)
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Correlation between use of cardiac output monitoring and the incidence of norepinephrine use
Prazo: Up to 28 days after surgery (length of intensive care unit stay)
|
Up to 28 days after surgery (length of intensive care unit stay)
|
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Correlation between use of cardiac output monitoring and the incidence of dobutamine use
Prazo: Up to 28 days after surgery (length of intensive care unit stay)
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Up to 28 days after surgery (length of intensive care unit stay)
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Correlation between use of cardiac output monitoring and the incidence of epinephrine use
Prazo: Up to 28 days after surgery (length of intensive care unit stay)
|
Up to 28 days after surgery (length of intensive care unit stay)
|
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Correlation between use of cardiac output monitoring and the length of norepinephrine infusion
Prazo: Up to 28 days after surgery (length of intensive care unit stay)
|
Up to 28 days after surgery (length of intensive care unit stay)
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Correlation between use of cardiac output monitoring and the length of dobutamine infusion
Prazo: Up to 28 days after surgery (length of intensive care unit stay)
|
Up to 28 days after surgery (length of intensive care unit stay)
|
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Correlation between use of cardiac output monitoring and the length of epinephrine infusion
Prazo: Up to 28 days after surgery (length of intensive care unit stay)
|
Up to 28 days after surgery (length of intensive care unit stay)
|
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Correlation between use of of cardiac output monitoring and the incidence of red blood cell transfusion
Prazo: Up to 28 days after surgery (length of intensive care unit stay)
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Up to 28 days after surgery (length of intensive care unit stay)
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Correlation between use of of cardiac output monitoring and the volume of fluid expansion during first day following cardiac surgery
Prazo: Up to 28 days after surgery (length of intensive care unit stay)
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Up to 28 days after surgery (length of intensive care unit stay)
|
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Correlation between use of of cardiac output monitoring and the incidence of postoperative complications
Prazo: Up to 28 days after surgery (length of intensive care unit stay)
|
Up to 28 days after surgery (length of intensive care unit stay)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Marc-Olivier Fischer, University Hospital, Caen
- Investigador principal: Fabien Dechanet, University Hospital, Caen
- Investigador principal: Raphaël D'Orlando, University Hospital, Caen
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- A14-D64-VOL.23
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