NCT00791648

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 653 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	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.
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.

Timeline

• Start date: 2009-07-01
• Primary completion: 2014-10-01
• Completion: 2014-12-01
• First posted: 2008-11-14
• Last updated: 2019-09-16
• Results posted: 2017-03-06

Locations

1 site across 1 country: United States