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- Ensayo clínico NCT01547455
Safety and Efficiency Study of Loading Dose Atorvastatin in Cardiac Surgery
Anti-inflammatory and Renoprotective Effect of Pretreatment Loading Dose Atorvastatin in CABG
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Acute kidney injury occurs up to 30% in cardiac surgery which influenced patients' mid-term and long-term outcomes. Furthermore, evidence shows patients who initiate renal placement therapy in hospital have higher mortality and morbility. The pathologies of Cardiac surgery-associated acute kidney injury (CSA-AKI) is not clear yet ,many researches find cardiopulmonary bypass is an independent risk factor in developing AKI, and inflammatory bursts during cardiopulmonary bypass (CPB) may play an important role in CSA-AKI.
Statins are reported to have anti-inflammatory reaction in many researches. In Some multicenter RCTS, Statins are reported to reduce myocardial infarction,atrial fibrillation and have renoprotective effects due to pleiotropic effects in percutaneous coronary intervention. While in the cardiac surgery settings, the renoprotective effect of statin is still controversial. The investigators believe the differences between surgery and PCI may contribute to the discrepancy. The investigators plan to test the renoprotective effect of atorvastatin in a randomized,double-blind control manner and try to explore the mechanism of this protective effect.
The investigators hypothesise loading dose atorvastatin pretreatment in elective coronary artery bypass grafting surgery may attenuate inflammatory response in CPB and therefore reduce postoperative AKI or help recovery from AKI.
The investigators randomize patients into two arms, the Atorvastatin group takes Atorvastatin 80mg 12h before surgery with another 40mg 2h before operation, the control arm takes placebo in the same regime. The investigators plan to compare the inflammatory cytokines at different time points and the incidence of AKI between the two groups. The investigators hope Atorvastatin group can decrease AKI incidence and has a lower level of inflammatory cytokines, what's more, the two have a good correlation in the time frame.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Beijing
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Beijing, Beijing, Porcelana, 100037
- Cardiovascular Institute&Fuwai Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- age > 18 years old
- elective coronary artery bypass surgery in CPB
Exclusion Criteria:
- emergent surgery
- re-operation
- acute kidney dysfunction
- chronic kidney disease
- GFR < 60ml/min
- liver dysfunction
- existing myopathy
- LEVF < 40%
- statin allergic or contradictive
- pregnancy
- breast feed period
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Atorvastatin
participants take 80mg Atorvastatin orally 12h before surgery with another 40mg 2h before surgery
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participants take 80mg Atorvastatin orally 12h before surgery with another 40mg 2h before surgery
Otros nombres:
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Comparador de placebos: Control
Participants randomized to Control arm take 80mg placebo 12h before surgery with another 40mg 2h before surgery
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Participants randomized to Control arm take 80mg placebo 12h before surgery with another 40mg 2h before surgery
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
acute kidney injury
Periodo de tiempo: 72 hours after surgery
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Proportion developing AKI using AKIN criteria(stage 1,stage 2, stage3).we
plan to measure serum creatinine in baseline, ICU admission,postoperative 6h、Day 1、Day 2 and Day 3.If multiple SCr was measured in one day ,then the highest value will be recorded.Also, we measure creatinine clearance via Cock-croft-Gault formula.
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72 hours after surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change of inflammatory biomarkers
Periodo de tiempo: 48h after surgery
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we plan to measure IL-6,IL-10,TNF-α and hsCRP at 6 time points: before surgery、after chest closure、postOp.6h、12h、24h
and 48h.Compare levels of cytokines between the two arms
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48h after surgery
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Requirement of renal replacement therapy
Periodo de tiempo: participants will be followed for the duration of hospital stay , an expected average of 2 weeks
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proportion need renal replacement therapy in hospital
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participants will be followed for the duration of hospital stay , an expected average of 2 weeks
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liver function
Periodo de tiempo: participants will be followed for the duration of hospital stay , an expected average of 2 weeks
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liver dysfunction defined as transaminase>3UNL normal level
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participants will be followed for the duration of hospital stay , an expected average of 2 weeks
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death
Periodo de tiempo: 30 days after discharge from hospital
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30 days after discharge from hospital
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MACCE events
Periodo de tiempo: 30 days after discharge from hospital
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30 days after discharge from hospital
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length of stay in intensive care unit
Periodo de tiempo: From admission to discharge from ICU
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An average of 2 days
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From admission to discharge from ICU
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length of stay in hospital after surgery
Periodo de tiempo: From surgery to discharge from hospital, an expected average of 7 days
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From surgery to discharge from hospital, an expected average of 7 days
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Weipeng Wang, MD,PhD, Chinese Academy of Medical Sciences, Fuwai Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Renales
- Enfermedades urológicas
- Insuficiencia renal
- Lesión renal aguda
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Antimetabolitos
- Agentes Anticolesterolémicos
- Agentes hipolipidémicos
- Agentes reguladores de lípidos
- Inhibidores de la hidroximetilglutaril-CoA reductasa
- Atorvastatina
Otros números de identificación del estudio
- 2011-1002-007
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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