Acute Kidney InjuryNCT01547455
Safety and Efficiency Study of Loading Dose Atorvastatin in Cardiac Surgery
A study testing Atorvastatin(Lipitor) in people with Acute Kidney Injury, run by Peking Union Medical College at 1 site in China.
Trial summary
Statins were reported to have pleiotropic effects including antiinflammatory, anti-oxidative stress effects and stabilise plaque in some conditions. Some researches indicate loading dose statin can reduce contrast induced nephropathy, and the levels of inflammatory markers were significantly decreased. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Atorvastatin(Lipitor)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- Apr 2012to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years old
- elective coronary artery bypass surgery in CPB
Who cannot join
- emergent surgery
- re-operation
- acute kidney dysfunction
- chronic kidney disease
- GFR < 60ml/min
- liver dysfunction
Show all 11Show fewer
- existing myopathy
- LEVF < 40%
- statin allergic or contradictive
- pregnancy
- breast feed period
Trial locations and contacts
1 site in 1 country.
China1 site
Cardiovascular Institute&Fuwai Hospital
Beijing, Beijing Municipality, 100037
About this study
Official title: Anti-inflammatory and Renoprotective Effect of Pretreatment Loading Dose Atorvastatin in CABG
Statins were reported to have pleiotropic effects including antiinflammatory, anti-oxidative stress effects and stabilise plaque in some conditions. Some researches indicate loading dose statin can reduce contrast induced nephropathy, and the levels of inflammatory markers were significantly decreased. The investigators hypothesis loading dose atorvastatin may attenuate inflammatory response during cardiopulmonary bypass (CPB) and therefore reduce postoperative acute kidney injury in cardiac surgery.
Read the detailed description
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.
- Conditions
- Acute Kidney Injury
- Being tested
- Atorvastatin(Lipitor), Placebo
- Keywords
- Statin, kidney function, antiinflammatory effect
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin(Lipitor)Drug
Also called Lipitor
participants take 80mg Atorvastatin orally 12h before surgery with another 40mg 2h before surgery
PlaceboDrug
Participants randomized to Control arm take 80mg placebo 12h before surgery with another 40mg 2h before surgery
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Experimental | participants take 80mg Atorvastatin orally 12h before surgery with another 40mg 2h before surgery Receives: Drug: Atorvastatin(Lipitor) |
| Control | Placebo comparator | Participants randomized to Control arm take 80mg placebo 12h before surgery with another 40mg 2h before surgery Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute kidney injury
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.
Measured: 72 hours after surgery
Secondary outcomes (7)
Change of inflammatory biomarkers
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
Measured: 48h after surgery
Requirement of renal replacement therapy
proportion need renal replacement therapy in hospital
Measured: participants will be followed for the duration of hospital stay , an expected average of 2 weeks
liver function
liver dysfunction defined as transaminase>3UNL normal level
Measured: participants will be followed for the duration of hospital stay , an expected average of 2 weeks
death
Measured: 30 days after discharge from hospital
MACCE events
Measured: 30 days after discharge from hospital
length of stay in intensive care unit
An average of 2 days
Measured: From admission to discharge from ICU
length of stay in hospital after surgery
Measured: From surgery to discharge from hospital, an expected average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Responsible party
- Principal investigator, Shan Zhou, Peking Union Medical College
- Investigators
- Weipeng Wang, MD,PhD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547455
- Sponsor's protocol ID
- 2011-1002-007
- Status last verified
- Jul 2013
- First submitted
- 26 Feb 2012
- Last updated
- 25 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-inflammatory and Renoprotective Effect of Pretreatment Loading Dose Atorvastatin in CABG
- ClinicalTrials.gov ID
- NCT01547455
- Acronym / sponsor ID
- 2011-1002-007
- Conditions
- Acute Kidney Injury
- Keywords
- Statin, kidney function, antiinflammatory effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Study start
- Apr 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Statins were reported to have pleiotropic effects including antiinflammatory, anti-oxidative stress effects and stabilise plaque in some conditions. Some researches indicate loading dose statin can reduce contrast induced nephropathy, and the levels of inflammatory markers were significantly decreased. The investigators hypothesis loading dose atorvastatin may attenuate inflammatory response during cardiopulmonary bypass (CPB) and therefore reduce postoperative acute kidney injury in cardiac surgery.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Experimental | Drug: Atorvastatin(Lipitor)participants take 80mg Atorvastatin orally 12h before surgery with another 40mg 2h before surgery |
| Control | Placebo comparator | Drug: PlaceboParticipants randomized to Control arm take 80mg placebo 12h before surgery with another 40mg 2h before surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age > 18 years old
- elective coronary artery bypass surgery in CPB
Key exclusion criteria (11 listed)
- emergent surgery
- re-operation
- acute kidney dysfunction
- chronic kidney disease
- GFR < 60ml/min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin(Lipitor)Also: Lipitorparticipants take 80mg Atorvastatin orally 12h before surgery with another 40mg 2h before surgery | Drug | Atorvastatin |
| PlaceboParticipants randomized to Control arm take 80mg placebo 12h before surgery with another 40mg 2h before surgery | Drug | Control |
Primary outcome
acute kidney injury
Time frame: 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.
7 secondary outcomes
Change of inflammatory biomarkers
Time frame: 48h after surgery
Requirement of renal replacement therapy
Time frame: participants will be followed for the duration of hospital stay , an expected average of 2 weeks
liver function
Time frame: participants will be followed for the duration of hospital stay , an expected average of 2 weeks
death
Time frame: 30 days after discharge from hospital
MACCE events
Time frame: 30 days after discharge from hospital
length of stay in intensive care unit
Time frame: From admission to discharge from ICU
length of stay in hospital after surgery
Time frame: From surgery to discharge from hospital, an expected average of 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weipeng Wang, MD,PhD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atorvastatin(Lipitor) in people with Acute Kidney Injury, run by Peking Union Medical College at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute kidney injury (time frame: 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2013.