N/A N=617 Randomized Quadruple-blind Prevention

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

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

Bottom Line

View on ClinicalTrials.gov: NCT00791648 ↗

Enrolled (actual)

617

Serious AEs

5.4%

Results posted

Mar 2017

Primary outcome: Primary: Number of Participants With Acute Kidney Injury — 64; 60 Participants — p=.75

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: atorvastatin (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vanderbilt University Medical Center
Primary completion: Oct 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Acute Kidney Injury	64; 60	.75
PRIMARY Number of Participants With Delirium	69; 75	.56
SECONDARY Number of Participants Requiring Dialysis	5; 3	.71
SECONDARY Liver Enzyme: Aspartate Aminotransferase Level	49; 52	.11
SECONDARY Number of Participants With Stroke	10; 7	.06
SECONDARY Number of Participants That Died	4; 1	.39
SECONDARY Mitochondrial Function--mtDNA Copy Number	0.40; .48; 0.3; 0.43	—
SECONDARY Mitochondrial Function--lactate / Pyruvate Ratio	0.04; 0.04; 0.06; 0.06; 0.04; 0.04	—
SECONDARY Mitochondrial Function--PGC-1alpha RNA Expression	0.54; 0.84; 1.02; 1.37	—
SECONDARY Urine Markers of Renal Injury	0.119; 0.098; 0.171; 0.169; 0.218; 0.219	—
SECONDARY Plasma Markers of Oxidative Stress: f2-Isoprostanes	29.4; 28.8; 41.6; 39; 32.3; 31.5	—
SECONDARY Plasma Markers of Oxidative Stress: Isofurans	45; 48.4; 59.9; 56.2; 57.6; 60.6	—
SECONDARY Urine Markers of Oxidative Stress: f2-Isoprostanes	1.369; 1.478; 1.750; 2.29; 2.71; 2.729	—
SECONDARY Urine Markers of Oxidative Stress: Isofurans	2.146; 2.146; 2.48; 2.48; 3.709; 3.709	—
SECONDARY Plasma Markers of Inflammation: Measurements of Neuronal Injury (Ubiquitin C-terminal Hydrolase-1)	6.2; 6.7; 12.3; 11.6; 12.8; 12.2	—
SECONDARY Plasma Markers of Inflammation: Blood Brain Barrier Disruption (S100 Calcium-binding Protein B)	17.5; 17; 163.9; 163.1; 46.1; 45	—

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.

Eligibility Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT00791648). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.