Statin Therapy To Limit Cognitive Dysfunction After Cardiac Surgery

Not Applicable

Withdrawn

• Conditions: Neurocognitive Dysfunction
• Interventions: Drug: atorvastatin

• Registration Number: NCT01186289
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-19
• Study First Submitted QC: 2010-08-20
• Study First Posted: 2010-08-23
• Study Start: 2010-10
• Status Verified: 2011-02
• Primary Completion: 2011-10
• Study Completion: 2012-10
• Last Update Submitted: 2015-10-11
• Last Update Posted: 2015-10-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
atorvastatin	atorvastatin	high dose atorvastatin therapy (80 mg/day) beginning 48 to 72-hours preoperatively and continuing until 6-weeks postoperatively
placebo	atorvastatin	-

Primary Outcome Measures

Name	Time	Method
Neurocognitive Dysfunction	6 weeks and 1 year post surgery	The subject will under go a battery of neurological test at baseline, 6 weeks post surgery and at 1 year post surgery to assess neurocognitive status.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States