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Gastrodin Prevents Cognitive Decline Related to Cardiopulmonary Bypass

Primary Purpose

Cognitive Decline

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
cognitive function
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Decline focused on measuring gastrodin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Anesthesiology, Union HospitalRecruiting

Outcomes

Primary Outcome Measures

Gastrodin markedly prevents cognitive decline related to cardiopulmonary bypass

Secondary Outcome Measures

neuropsychological tests

Full Information

First Posted
February 27, 2006
Last Updated
February 27, 2006
Sponsor
Huazhong University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT00297245
Brief Title
Gastrodin Prevents Cognitive Decline Related to Cardiopulmonary Bypass
Study Type
Interventional

2. Study Status

Record Verification Date
January 2006
Overall Recruitment Status
Unknown status
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Huazhong University of Science and Technology

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline
Keywords
gastrodin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cognitive function
Primary Outcome Measure Information:
Title
Gastrodin markedly prevents cognitive decline related to cardiopulmonary bypass
Secondary Outcome Measure Information:
Title
neuropsychological tests

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shihai Zhang, M.D.,Ph.D.
Phone
862-785-726-834
Email
zhangshh@public.wh.hb.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Shihai Zhang, M.D., Ph.D.
Phone
862-785-726-834
Email
zhangshh@public.wh.hb.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shihai Zhang
Organizational Affiliation
Department of Anesthesiology, Union Hosiptal, Tongji Medical College, Huazhong University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shihai Zhang, M.D., Ph.D.
Organizational Affiliation
Department of Anesthesiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology, Union Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shihai Zhang, M.D., Ph.D.
Phone
862-785-726-834
Email
zhangshh@public.wh.hb.cn
First Name & Middle Initial & Last Name & Degree
Shihai Zhang, M.D., Ph.D.

12. IPD Sharing Statement

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Gastrodin Prevents Cognitive Decline Related to Cardiopulmonary Bypass

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