Back to resultsThe Effect of Atorvastatin on Prevention of Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery
Primary Purpose
Aortic Surgery, Acute Kidney Injury
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Atorvastatin
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Aortic Surgery focused on measuring aortic surgery, postoperative acute kidney injury, statin, the patient undergoing aortic surgery
Eligibility Criteria
Inclusion Criteria:
- the patients undergoing aortic surgery
- the age: 20~80 yrs
Exclusion Criteria:
- taking the statin before the admission
- having preoperative severe renal dysfunction (eGFR < 15 ml/min per 1.73 m2)
- past history of liver disease OR serum AST/ALT increase > 2-fold from upper normal limit
- past history of myopathy, myasthenia gravis, rhabdomyolysis OR increased creatinine kinase
- drug or alcohol abuser
- hypothyroidism
- taking Macrolide, Azole antifungals, H2 antagonists, Cyclosporine, Omeprazole, Amiodarone, Fibrates and Niacin
Sites / Locations
- Department of Anesthesiology and Pain Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
atrovastatin
placebo
Arm Description
Outcomes
Primary Outcome Measures
Serum creatinine increase ≥0.3 mg/dl OR increase to 1.5-fold from baseline OR Urine output(U/O) < 0.5 ml/kg/h for 6 h
Secondary Outcome Measures
Serum creatinine increase >2.0-3.0-fold from baseline OR U/O < 0.5 ml/kg/h for 12 h
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02157337
Brief Title
The Effect of Atorvastatin on Prevention of Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery
Official Title
The Effect of Atorvastatin on Prevention of Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 12, 2014 (Actual)
Primary Completion Date
May 29, 2015 (Actual)
Study Completion Date
May 29, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Acute kidney injury(AKI) is a common and severe complication after the cardiac surgery. Postoperative AKI increases the in-hospital stay, intensive care unit(ICU) stay and postoperative mortality. Aortic surgery is the most risky surgery that causes the postoperative AKI, and the incidence of AKI after aortic surgery is about 50%.
Statin is a 3-hydroxy-3-methyl-glutaryl co-enzyme A (HMG CoA) reductase inhibitors and is used primarily to lower the level of plasma cholesterol. Apart from the antilipid effect, statin has pleiotropic effects include anti-inflammation, decrease of oxidative stress, recovery of endothelial cell injury and stabilization of thrombus.
The pathology of AKI after aortic surgery include not only hypoperfusion of renal blood flow but also thromboembolism, inflammatory reaction after use of cardiopulmonary bypass(CPB) and oxidative stress. Therefore, the incidence of AKI after aortic surgery can be expected to decrease after the perioperative use of statin because of the pleiotropic effects of it. The aim of this study is to examine the association between preoperative statin treatment and the incidence of postoperative acute kidney injury(AKI) in patients undergoing aortic surgery
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Surgery, Acute Kidney Injury
Keywords
aortic surgery, postoperative acute kidney injury, statin, the patient undergoing aortic surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
atrovastatin
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
80 mg (PO) once daily for 6 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
80 mg (PO) once daily for 6 days
Primary Outcome Measure Information:
Title
Serum creatinine increase ≥0.3 mg/dl OR increase to 1.5-fold from baseline OR Urine output(U/O) < 0.5 ml/kg/h for 6 h
Time Frame
up to 7 days after the aortic surgery
Secondary Outcome Measure Information:
Title
Serum creatinine increase >2.0-3.0-fold from baseline OR U/O < 0.5 ml/kg/h for 12 h
Time Frame
up to 7 days after the aortic surgery
Other Pre-specified Outcome Measures:
Title
Serum creatinine increase >3.0-fold from baseline OR serum creatinine ≥4.0 mg/dl with an acute increase of at least 0.5 mg/dl OR U/O <0.3 ml/kg/h for 24 h OR anuria for 12 h OR need for RRT
Time Frame
up to 7 days after the aortic surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
the patients undergoing aortic surgery
the age: 20~80 yrs
Exclusion Criteria:
taking the statin before the admission
having preoperative severe renal dysfunction (eGFR < 15 ml/min per 1.73 m2)
past history of liver disease OR serum AST/ALT increase > 2-fold from upper normal limit
past history of myopathy, myasthenia gravis, rhabdomyolysis OR increased creatinine kinase
drug or alcohol abuser
hypothyroidism
taking Macrolide, Azole antifungals, H2 antagonists, Cyclosporine, Omeprazole, Amiodarone, Fibrates and Niacin
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Effect of Atorvastatin on Prevention of Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery
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