- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02661269
Relation Between the Increase of Peripheral Edema by Fluid Therapy and the Decrease in Microcirculatory Vesseldensity
Can videomicroscopy of the sublingual microcirculation detect the increase in edema before peripheral edema will appear? By measuring the decrease in vesseldensity after strong positive fluid balances within septic patients versus euvolemic post-cardiac surgery patients. Measuring reactance and resistance (BIVA method) to determine volume status.
Primary outcome:
- Total vessel density (TVD)
Secondary outcome:
- Fluid balance
- BIVA measurements (reactance & resistance)
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
There are a lot of methods to determine if a patient is fluid-responsive, however a moment to stop fluid therapy is lacking. So the purpose of this study is to find a 'stop' moment for fluid therapy before peripheral edema will be present.
With sublingual measurements of the vessel density with the Cytocam-IDF, comparing the septic patients with fluid overload , euvolemic post-cardiac surgery patients at the arrival on the ICU and healthy volunteers we can determine if there is a decrease in vessel density during fluid loading.
To give a accurate view on fluid overload we include a bio-impedance measurement of reactance and resistance. Fluid balances are recorded very accurate by our electronic patient record.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Friesland
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Leeuwarden, Friesland, Holanda, 8901 BR
- Medical Centre Leeuwarden
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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:
- after cardiac surgery
- septic patient with a fluid balance of 4L +
Exclusion Criteria:
- recent maxillofacial surgery
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Septic patients
Septic patients with fluid overload (fluid balance + 4 L)
|
Measuring total vessel density with the Cytocam-IDF camera.
measuring resistance and reactance with the BIVA method.
|
|
Post-cardiac surgery patients
Patients after cardiac surgery, at arrival on ICU.
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Measuring total vessel density with the Cytocam-IDF camera.
measuring resistance and reactance with the BIVA method.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Difference in vessel density (mm/mm2) of the sublingual microcirculation between the two groups.
Prazo: Cardiac surgery within 4 hours of ICU admittance, 1 offline total vessel density measurement, Septic patients +/- third day of ICU admittance, 1 offline total vessel density measurement.
|
With the Cytocam-IDF we make movies off the sublingual microcirculation for 6 seconds on 3 different spots, with offline analysis we calculate a mean total vessel density (total surface of vessels divided by total area surface). The cardiac surgery group will be measured within 4 hours of admittance on the ICU. The septic patients group will be measured on the moment that the highest fluid balance during the ICU stay, so on the moment that there will be started with diuretics of renal replacement therapy to induce a negative fluid balance. |
Cardiac surgery within 4 hours of ICU admittance, 1 offline total vessel density measurement, Septic patients +/- third day of ICU admittance, 1 offline total vessel density measurement.
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
The correlation between a increasing fluid balance and the total vessel density in both groups separately.
Prazo: The cumulative fluidbalance (L) will be noted at the same moment as the microcirculation movies are made, this will be the cumulative fluid balance as measured on the ICU.
|
The cumulative fluidbalance (L) will be noted at the same moment as the microcirculation movies are made, this will be the cumulative fluid balance as measured on the ICU.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: E.C. Boerma, MD-PhD, Medical Centre Leeuwarden
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- nWMO 127
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