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Central Nerve System Protection Effect of Simvastatin Undergoing Cardiac Valve Replacement

Effects of perioperative simvastatin treatment on central nerve system in patients receiving cardiac valve replacement surgery

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14005164
Enrollment
Unknown
Registered
2014-06-01
Start date
2014-08-26
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neurological complications after cardiac surgery

Interventions

Statin Group:simvastatin
Control group:Placebo (starch tablets)

Sponsors

Sun yat-sen memorial hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1)Patients scheduled to undergo valve replacement with CBP; (2)Over 18 years old; (3)Patients signed the consent form.

Exclusion criteria

Exclusion criteria: Patients were excluded if they were unable to read or had less than a sixth grade education or had a history of symptomatic cerebrovascular disease (eg, stroke with a residual deficit), psychiatric illness (any clinical diagnoses requiring therapy), allergy to simvastatin, renal failure (serum creatinine 2 mg/dL), liver disease (liver function tests 1.5 times the upper limit of normal), higher alcohol consumption (2 drinks/d), or were during pregnancy or lactation, taking calcium-channel blockers as Mibefradil, or can't be regularly follow up.

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative central nervous system;

Secondary

MeasureTime frame
brain damage markers (as NSE, S100 beta);Inflammatory markers (as IL-6; IL-8; IL1 beta; IL-10; CRP);Length of ICU and hospital stay;cost of Hospitalization;30-day major adverse cardiac and cerebrovascular events;

Countries

China

Contacts

Public ContactHua Ping
huaping88@sina.com+86 13609716875

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 27, 2026