Safety and Efficiency Study of Loading Dose Atorvastatin in Cardiac Surgery
Anti-inflammatory and Renoprotective Effect of Pretreatment Loading Dose Atorvastatin in CABG
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Beijing
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Beijing、Beijing、中国、100037
- Cardiovascular Institute&Fuwai Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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
他の名前：
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プラセボコンパレーター：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
acute kidney injury
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change of inflammatory biomarkers
時間枠：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
時間枠：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
時間枠：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
時間枠：30 days after discharge from hospital
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30 days after discharge from hospital
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MACCE events
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Weipeng Wang, MD,PhD、Chinese Academy of Medical Sciences, Fuwai Hospital
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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