The Effect of Atorvastatin on Prevention of Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery

NCT02157337 | Completed Phase 4

• 1 other identifier: 4-2013-0551
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Conditions

Aortic Surgery; Acute Kidney Injury

Keywords

aortic surgery; postoperative acute kidney injury; statin; the patient undergoing aortic surgery

Outcome Measures

Primary Outcomes (1)

• 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

  up to 7 days after the aortic surgery

Secondary Outcomes (1)

• Serum creatinine increase >2.0-3.0-fold from baseline OR U/O < 0.5 ml/kg/h for 12 h

  up to 7 days after the aortic surgery

Other Outcomes (1)

• 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

  up to 7 days after the aortic surgery

Study Arms (2)

atrovastatin

EXPERIMENTAL

Drug: Atorvastatin

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

Atorvastatin DRUG

80 mg (PO) once daily for 6 days

atrovastatin

placebo DRUG

80 mg (PO) once daily for 6 days

placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• the patients undergoing aortic surgery
• the age: 20\~80 yrs

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2014
• First Posted: June 6, 2014
• Study Start: March 12, 2014
• Primary Completion: May 29, 2015
• Study Completion: May 29, 2015
• Last Updated: January 25, 2017

Record last verified: 2017-01

Locations

KR (1)