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Gastrodin Prevents Cognitive Decline Related to Cardiopulmonary Bypass

NCT ID: NCT00297245

Last Updated: 2006-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2006-05-31

Brief Summary

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The incidence of cognitive decline related to CPB ranges from 20% to 80%, which may affect length of hospital stay, quality of life, the rehabilitation process, and work performance.However, there is no method to prevent the decline.Gastrodin,the active constituent of gastrodia elata, has been widely used for the treatment of paralysis, hemiplegia, headache, vertigo, and Alzheimer's disease. Gastrodin is safe. No severe side-effect has been observed in the treatment. We postulate that gastrodin would attenuate the causative parameters of cognitive dysfunction related to CPB and would be an effective drug to prevent the decline as a result.

Detailed Description

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Cardiac surgery with cardiopulmonary bypass (CPB) is one of the most frequently performed operations. Neurobehavioral disorders, including neuropsychiatric and neuropsychological deficits, are a very frequently reported sequela of valve replacement or coronary artery bypass grafting (CABG) surgery. CPB is associated with significant cerebral morbidity. The incidence of cognitive decline related to CPB ranges from 20% to 80%, which may affect length of hospital stay, quality of life, the rehabilitation process, and work performance. Neurocognitive decline can present days to weeks after surgery and may remain a permanent disorder. Many pharmacologic strategies have been proposed or investigated for preventing post-CPB cognitive decline, but to our knowledge, none of these drugs has been systematically evaluated for efficacy in preventing post-CPB cognitive decline.

The causative parameters of cognitive dysfunction associated with CPB include cerebral ischemia secondary to either microemboli or hypoperfusion, intraoperative cerebrovascular risk factors such as the duration of CPB, inflammatory response, cerebral glutamine release, free radicals, and NO release.

Gastrodia elata, a famous Chinese medical herb, has effects on preventing ischemic brain injury, neuronal cell damage or apoptosis, suppressing inflammatory response, inhibiting glutamine receptors and nNOS, and scavenging free radicals. Gastrodin (4-\[hydroxymethyl\]phenyl-β-D-glucopyranoside), the primary active constituent of gastrodia elata, has been widely used for the treatment of paralysis, hemiplegia, headache, vertigo, and Alzheimer's disease. Based on its pharmacological effects, we postulated that gastrodin would attenuate the causative parameters of cognitive dysfunction related to CPB and would be an effective drug to prevent the decline as a result.

Conditions

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Cognitive Decline

Keywords

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gastrodin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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cognitive function

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients undergo mitral valve replacement surgery.

Exclusion Criteria

* Thrombi in left atrium, a history of symptomatic cerebrovascular disease, diabetes, psychiatric illness, renal disease, or active liver disease, less than a seven-grade education, or who cannot read.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Principal Investigators

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Shihai Zhang

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Union Hosiptal, Tongji Medical College, Huazhong University of Science and Technology

Shihai Zhang, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Locations

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Department of Anesthesiology, Union Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shihai Zhang, M.D.,Ph.D.

Role: CONTACT

Phone: 862-785-726-834

Email: [email protected]

Shihai Zhang, M.D., Ph.D.

Role: CONTACT

Phone: 862-785-726-834

Email: [email protected]

Facility Contacts

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Shihai Zhang, M.D., Ph.D.

Role: primary

Other Identifiers

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21124941

Identifier Type: -

Identifier Source: org_study_id