Short-term Atorvastatin's Effect on Acute Kidney Injury Following Cardiac Surgery

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

653 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2014-12-31

Brief Summary

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Aim1a: Statin naive patient's scheduled for cardiac surgery will be randomized to 80mg atorvastatin or placebo on the day prior to surgery and then 40mg daily thereafter until hospital discharge to test the hypothesis that short-term atorvastatin use decreases:

1. acute kidney injury following cardiac surgery.
2. postoperative delirium following cardiac surgery.

Aim1b: Patients using statins preoperatively will be randomized to atorvastatin 80mg or placebo on day of surgery and 40mg or placebo on postop day 1 with resumption of preoperative statin therapy on postop day 2 to test the hypothesis that short-term atorvastatin use decreases:

1. acute kidney injury following cardiac surgery.
2. postoperative delirium following cardiac surgery.

Endpoints include glomerular filtration, urine and plasma markers of renal dysfunction, markers of oxidative stress, mitochondrial function, systemic inflammatory markers, delirium, dialysis, stroke, myocardial infarction, time to extubation, ICU length of stay, and death.

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Detailed Description

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Conditions

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Acute Kidney Injury Post-Operative Delirium Icu Delirium Acute Renal Failure Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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statin

Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.

Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1.

Group Type EXPERIMENTAL

atorvastatin

Intervention Type DRUG

Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.

Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1.

placebo

Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.

Aim 2 control: placebo the day of cardiac surgery and postop day 1.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.

Aim 2 control: placebo the day of cardiac surgery and postop day 1.

Interventions

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atorvastatin

Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.

Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1.

Intervention Type DRUG

placebo

Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.

Aim 2 control: placebo the day of cardiac surgery and postop day 1.

Intervention Type DRUG

Other Intervention Names

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Lipitor

Eligibility Criteria

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Inclusion Criteria

* open heart surgery

Exclusion Criteria

* acute coronary syndrome with troponin leak or unrelenting angina
* liver dysfunction (transaminases 2x normal)
* history of myopathy or liver dysfunction on prior statin therapy
* use of potent CYP3A4 inhibitors such as antifungal azoles, macrolide antibiotics, HIV protease inhibitors, and nefazodone.
* pregnancy or breast feeding
* cyclosporine use
* dialysis
* history of kidney transplant
* fibrate users who cannot stop fibrate use.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No