- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01547455
Safety and Efficiency Study of Loading Dose Atorvastatin in Cardiac Surgery
Anti-inflammatory and Renoprotective Effect of Pretreatment Loading Dose Atorvastatin in CABG
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Beijing
-
Beijing, Beijing, Kina, 100037
- Cardiovascular Institute&Fuwai Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Atorvastatin
participants take 80mg Atorvastatin orally 12h before surgery with another 40mg 2h before surgery
|
participants take 80mg Atorvastatin orally 12h before surgery with another 40mg 2h before surgery
Andra namn:
|
|
Placebo-jämförare: Control
Participants randomized to Control arm take 80mg placebo 12h before surgery with another 40mg 2h before surgery
|
Participants randomized to Control arm take 80mg placebo 12h before surgery with another 40mg 2h before surgery
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
acute kidney injury
Tidsram: 72 hours after surgery
|
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.
|
72 hours after surgery
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change of inflammatory biomarkers
Tidsram: 48h after surgery
|
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
|
48h after surgery
|
|
Requirement of renal replacement therapy
Tidsram: participants will be followed for the duration of hospital stay , an expected average of 2 weeks
|
proportion need renal replacement therapy in hospital
|
participants will be followed for the duration of hospital stay , an expected average of 2 weeks
|
|
liver function
Tidsram: participants will be followed for the duration of hospital stay , an expected average of 2 weeks
|
liver dysfunction defined as transaminase>3UNL normal level
|
participants will be followed for the duration of hospital stay , an expected average of 2 weeks
|
|
death
Tidsram: 30 days after discharge from hospital
|
30 days after discharge from hospital
|
|
|
MACCE events
Tidsram: 30 days after discharge from hospital
|
30 days after discharge from hospital
|
|
|
length of stay in intensive care unit
Tidsram: From admission to discharge from ICU
|
An average of 2 days
|
From admission to discharge from ICU
|
|
length of stay in hospital after surgery
Tidsram: From surgery to discharge from hospital, an expected average of 7 days
|
From surgery to discharge from hospital, an expected average of 7 days
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Weipeng Wang, MD,PhD, Chinese Academy of Medical Sciences, Fuwai Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2011-1002-007
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