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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00791648
First Posted: November 14, 2008
Last Update Posted: September 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Frederic T Billings IV, Vanderbilt University Medical Center
  Purpose

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.


Condition Intervention
Acute Kidney Injury Post-Operative Delirium Icu Delirium Acute Renal Failure Delirium Drug: atorvastatin Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Short-term Atorvastatin's Effect on Acute Kidney Injury Following Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Frederic T Billings IV, Vanderbilt University Medical Center:

Primary Outcome Measures:
  • Number of Participants With Acute Kidney Injury [ Time Frame: postoperative day 2 ]
  • Number of Participants With Delirium [ Time Frame: while in ICU (about 2 days) ]

Secondary Outcome Measures:
  • Number of Participants Requiring Dialysis [ Time Frame: while in ICU (about 2 days) ]
  • Urine Markers of Renal Injury [ Time Frame: at randomization, anesthesia induction, 30 minutes into cardiopulm bypass (CPB), after CPB, ICU admission, 6 hours postop, 12 hours postop, and Post op Day (POD) 1, 2, 3. ]
  • Plasma Markers of Inflammation [ Time Frame: at randomization, anesthesia induction, 30 minutes into cardiopulmonary bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3. ]
  • Liver Enzyme: Aspartate Aminotransferase Level [ Time Frame: postoperative day 1 ]
  • Number of Participants With Stroke [ Time Frame: while in ICU (about 2 days) ]
  • Number of Participants That Died [ Time Frame: until postoperative hospital discharge (about 7 days) ]
  • Plasma and Urine Markers of Oxidative Stress (f2-Isoprostanes, Isofurans) [ Time Frame: at randomization, anesthesia induction, 30 minutes into cardiopulmonary bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3. ]
  • Mitochondrial Function [ Time Frame: at randomization, anesthesia induction, 30 minutes into cardiopulmonary bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3. ]
    mtDNA copy number, lactate / pyruvate ratio, PGC-1alpha RNA expression


Enrollment: 653
Study Start Date: July 2009
Study Completion Date: December 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: statin 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.

Placebo Comparator: placebo 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.


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791648


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
Principal Investigator: Frederic T. Billings, IV, MD Vanderbilt University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Frederic T Billings IV, Assistant Professor of Anesthesiology and Critical Care Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00791648     History of Changes
Other Study ID Numbers: 081238
First Submitted: November 12, 2008
First Posted: November 14, 2008
Results First Submitted: November 11, 2016
Results First Posted: September 4, 2017
Last Update Posted: September 4, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Frederic T Billings IV, Vanderbilt University Medical Center:
aki
delirium
statin
short-term
cardiac

Additional relevant MeSH terms:
Wounds and Injuries
Delirium
Renal Insufficiency
Acute Kidney Injury
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Kidney Diseases
Urologic Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors