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Completed

NCT Number: NCT00791648

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

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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Key information

Conditions

Acute Kidney Injury Acute Renal Failure Confusion Delirium Emergence Delirium Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications ICU Delirium Kidney Diseases Male Urogenital Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Post-operative Delirium Postoperative Complications Renal Insufficiency Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

atorvastatin

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.

Other names: Lipitor

Placebo

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.

Primary outcomes

  1. Number of Participants With Acute Kidney Injury

    Time frame: postoperative day 2

  2. Number of Participants With Delirium

    Time frame: while in ICU (about 2 days)

Secondary outcomes

  1. Number of Participants Requiring Dialysis

    Time frame: while in ICU (about 2 days)

  2. Liver Enzyme: Aspartate Aminotransferase Level

    Time frame: postoperative day 1

  3. Number of Participants With Stroke

    Time frame: while in ICU (about 2 days)

  4. Number of Participants That Died

    Time frame: until postoperative hospital discharge (about 7 days)

  5. Mitochondrial Function--mtDNA Copy Number

    Time frame: anesthesia induction and POD 1

    mtDNA copy number

  6. Mitochondrial Function--lactate / Pyruvate Ratio

    Time frame: anesthesia induction, after CPB, and POD 1

    lactate / pyruvate ratio

  7. Mitochondrial Function--PGC-1alpha RNA Expression

    Time frame: anesthesia induction and POD 1

    PGC-1alpha RNA expression

  8. Urine Markers of Renal Injury

    Time frame: anesthesia induction, 30 minutes into cardiopulm bypass (CPB), after CPB, ICU admission, 6 hours postop, and Post op Day (POD) 1, 2, 3

    tissue inhibitor metaloproteinase-2 x insulin-like growth factor binding protein-7

  9. Plasma Markers of Oxidative Stress: f2-Isoprostanes

    Time frame: anesthesia induction, 30 minutes into cardiopulmonary bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3.

  10. Plasma Markers of Oxidative Stress: Isofurans

    Time frame: anesthesia induction, 30 minutes into cardiopulmonary bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3.

  11. Urine Markers of Oxidative Stress: f2-Isoprostanes

    Time frame: anesthesia induction, 30 minutes into cardiopulmonary bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3.

  12. Urine Markers of Oxidative Stress: Isofurans

    Time frame: anesthesia induction, 30 minutes into cardiopulmonary bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3.

  13. Plasma Markers of Inflammation: Measurements of Neuronal Injury (Ubiquitin C-terminal Hydrolase-1)

    Time frame: anesthesia induction, ICU admission, and POD 1

    measurements of neuronal injury (ubiquitin C-terminal hydrolase-1)

  14. Plasma Markers of Inflammation: Blood Brain Barrier Disruption (S100 Calcium-binding Protein B)

    Time frame: anesthesia induction, ICU admission, and POD 1

    measurements of blood brain barrier disruption (S100 calcium-binding protein B)

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Nov 14, 2008
Registry last updated
Sep 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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