Stroke Volume Analysis During Aortic Valve Replacement Trial (standart)
7 de agosto de 2014 atualizado por: Michael Sander, Charite University, Berlin, Germany
Compromised peripheral tissue oxygenation during surgery may lead to worse patient outcome, mainly due to post-operative infections or heart failure.
Insufficient stroke volume and/or cardiac output due to hypovolemia or cardiac defects play a central role in causing poor peripheral tissue oxygenation.
In order to assess stroke volume, there are numerous invasive and non-invasive methods available.
Up to the present date it is unknown, if these methods may by used interchangeably in patients with severe cardiac defects like aortic stenosis.
Visão geral do estudo
Status
Desconhecido
Tipo de estudo
Observacional
Inscrição (Antecipado)
68
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Michael Sander, MD
- Número de telefone: +4930450531052
- E-mail: michael.sander@charite.de
Locais de estudo
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Berlin, Alemanha, 10117
- Recrutamento
- Charité Universitätsmedizin Berin
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Subinvestigador:
- Felix Balzer, MD
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Contato:
- Michael Sander, MD
- Número de telefone: +4930450531052
- E-mail: michael.sander@charite.de
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Subinvestigador:
- Sascha Treskatsch, MD
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Subinvestigador:
- Marit Habicher, MD
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Subinvestigador:
- Viktor Mezger, MD
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Cardiac surgery at a university hospital
Descrição
Inclusion Criteria:
- scheduled transcatheter aortic valve implantation
- signed patient consent form
- aged 18 or older by time of surgery
- no participation in other clinical trials
Exclusion Criteria:
- pregnant or breast-feeding women
- emergency surgery
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Hemodynamic optimisation
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No hemodynamic optimisation
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Measurement of stroke volume (ml) before TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography, (3) pulmonary thermodilution via pulmonary artery catheter
Prazo: Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Measurement of cardiac output (l/min) before TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography, (3) pulmonary thermodilution via pulmonary artery catheter
Prazo: Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Measurement of stroke volume (ml) after TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter
Prazo: After surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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After surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Accordance of stroke volume and cardiac output measurements assessed by (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter AFTER ADMINISTRATION OF FLUID BOLUS
Prazo: Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Accordance of stroke volume and cardiac output measurements assessed by two of the mentioned methods [i.e. (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter]
Prazo: Before and after Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Before and after Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Measurement of cardiac output (l/min) after TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter
Prazo: After Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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After Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Outras medidas de resultado
Medida de resultado |
Prazo |
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oxygen delivery (ml)
Prazo: Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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image quality of echocardiography
Prazo: Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Length of stay on ICU
Prazo: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Cumulative rate of infections
Prazo: after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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incidence of delirium after surgery
Prazo: after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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dosage of inotropic medication (mg/d)
Prazo: after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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length of hospital stay
Prazo: after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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incidence of stroke
Prazo: after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Michael Sander, MD, Charite University, Berlin, Germany
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de maio de 2014
Conclusão Primária (Antecipado)
1 de maio de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
20 de maio de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
2 de junho de 2014
Primeira postagem (Estimativa)
5 de junho de 2014
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
8 de agosto de 2014
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de agosto de 2014
Última verificação
1 de agosto de 2014
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- EA1/060/13
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