Trial record 6 of 271 for:
"Kidney Failure, Acute"
Short-term Atorvastatin's Effect on Acute Kidney Injury Following Cardiac Surgery
This study is currently recruiting participants.
Verified July 2011 by Vanderbilt University
Sponsor:
Vanderbilt University
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00791648
First received: November 12, 2008
Last updated: July 12, 2011
Last verified: July 2011
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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:
- acute kidney injury following cardiac surgery.
- 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:
- acute kidney injury following cardiac surgery.
- 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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 Vanderbilt University:
Primary Outcome Measures:
- acute kidney injury [ Time Frame: at randomization, at anesthsia induction, and postoperative days 1, 2, and 3, up to 6 months. ] [ Designated as safety issue: No ]
- delirium [ Time Frame: at randomization, daily postoperatively while in ICU, and up to 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- dialysis [ Time Frame: until postoperative ICU discharge. ] [ Designated as safety issue: No ]
- 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 POD 1, 2, 3. ] [ Designated as safety issue: No ]
- plasma markers of inflammation [ Time Frame: at randomization, anesthesia induction, 30 minutes into cardiopulm bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3. ] [ Designated as safety issue: No ]
- liver enzymes [ Time Frame: postoperative day 1 ] [ Designated as safety issue: Yes ]
- stroke [ Time Frame: until postoperative ICU discharge ] [ Designated as safety issue: No ]
- death [ Time Frame: until postoperative hospital discharge & at 6 months ] [ Designated as safety issue: No ]
- plasma and urine markers of oxidative stress (f2-Isoprostanes, isofurans) [ Time Frame: at randomization, anesthesia induction, 30 minutes into cardiopulm bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3. ] [ Designated as safety issue: No ]
- mitochondrial function [ Time Frame: at randomization, anesthesia induction, 30 minutes into cardiopulm bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3. ] [ Designated as safety issue: No ]mtDNA copy number, lactate / pyruvate ratio, PGC-1alpha RNA expression
| Estimated Enrollment: | 820 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00791648
Contacts
| Contact: Frederic T. Billings, IV, MD | 615-936-8487 | frederic.t.billings@vanderbilt.edu |
Locations
| United States, Tennessee | |
| Vanderbilt University Medical Center | Recruiting |
| Nashville, Tennessee, United States, 37212 | |
| Contact: Frederic T. Billings, IV, MD 615-343-6479 frederic.t.billings@vanderbilt.edu | |
Sponsors and Collaborators
Vanderbilt University
Investigators
| Principal Investigator: | Frederic T. Billings, IV, MD | Vanderbilt University |
More Information
No publications provided by Vanderbilt University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Frederic T. Billings, IV, MD, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00791648 History of Changes |
| Other Study ID Numbers: | 081238 |
| Study First Received: | November 12, 2008 |
| Last Updated: | July 12, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Vanderbilt University:
|
aki delirium statin short-term cardiac |
Additional relevant MeSH terms:
|
Acute Kidney Injury Delirium Renal Insufficiency Confusion Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Kidney Diseases |
Urologic Diseases Atorvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013