N/A
Completed N=617
Short-term Atorvastatin's Effect on Acute Kidney Injury Following Cardiac Surgery
Chronic Kidney Disease · Post-Operative Delirium · Icu Delirium · Acute Renal Failure
Source: ClinicalTrials.gov NCT00791648 ↗
Enrolled (actual)
617
Serious AEs
5.4%
Results posted
Mar 2017
Primary outcomePrimary: Number of Participants With Acute Kidney Injury — 64; 60 Participants — p=.75
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.
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 | — |
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.
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. Informational only — not medical advice.