- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01547455
Safety and Efficiency Study of Loading Dose Atorvastatin in Cardiac Surgery
Anti-inflammatory and Renoprotective Effect of Pretreatment Loading Dose Atorvastatin in CABG
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Beijing
-
Beijing, Beijing, Kina, 100037
- Cardiovascular Institute&Fuwai Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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
Andre navn:
|
Placebo komparator: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
acute kidney injury
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change of inflammatory biomarkers
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 30 days after discharge from hospital
|
30 days after discharge from hospital
|
|
MACCE events
Tidsramme: 30 days after discharge from hospital
|
30 days after discharge from hospital
|
|
length of stay in intensive care unit
Tidsramme: From admission to discharge from ICU
|
An average of 2 days
|
From admission to discharge from ICU
|
length of stay in hospital after surgery
Tidsramme: From surgery to discharge from hospital, an expected average of 7 days
|
From surgery to discharge from hospital, an expected average of 7 days
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Weipeng Wang, MD,PhD, Chinese Academy of Medical Sciences, Fuwai Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2011-1002-007
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