Safety and Efficiency Study of Loading Dose Atorvastatin in Cardiac Surgery
Anti-inflammatory and Renoprotective Effect of Pretreatment Loading Dose Atorvastatin in CABG
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Beijing
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Beijing, Beijing, China, 100037
- Cardiovascular Institute&Fuwai Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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
Outros nomes:
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Comparador de Placebo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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acute kidney injury
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change of inflammatory biomarkers
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 30 days after discharge from hospital
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30 days after discharge from hospital
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MACCE events
Prazo: 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
Prazo: 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
Prazo: 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
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
- 2011-1002-007
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