Statin Therapy To Limit Cognitive Dysfunction After Cardiac Surgery



Status:Withdrawn
Conditions:Cognitive Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:50 - Any
Updated:4/21/2016
Start Date:October 2010
End Date:October 2012

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The primary aim of our prospective, randomized, double-blind interventional clinical trial
is to determine the effectiveness of high dose atorvastatin therapy to reduce post operative
cognitive dysfunction (POCD) in patients undergoing cardiac valve surgery. We hypothesize
that therapy with high dose atorvastatin will significantly reduce the incidence and/or
severity of POCD.


Inclusion Criteria:

- Fifty informed and consenting patients for cardiac valve surgery with CPB , greater
than 50 years of age and under the care of one or more of the investigators or
consultants will be prospectively enrolled over a one-year period (plus one-year for
follow-up).

Exclusion Criteria:

- Patients with a history of the following disease entities will be excluded:

- symptomatic cerebrovascular disease with substantial residual deficit, alcohol
abuse, psychiatric illness, renal failure (creatinine>2.0),

- hepatic dysfunction (ALT or AST > 1.5 x ULN), history of allergy or myopathy
with statin therapy, pregnant or breastfeeding women or other comorbidities that
in the opinion of the investigator could limit patient participation. Exclusion
criteria are designed to limit confounding and enhance differentiation of
deficits related to surgery and or treatment.

- Patients who are unable to read and thus unable to complete the neurocognitive
testing will also be excluded.

- Patients having concomitant carotid endarterectomy or other vascular surgery
will also be excluded to provide a more homogeneous sample for comparison.
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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