Gastrodin Prevents Cognitive Decline Related to Cardiopulmonary Bypass

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by Huazhong University of Science and Technology.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00297245
First received: February 27, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Cognitive Decline
Drug: cognitive function
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention

Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • Gastrodin markedly prevents cognitive decline related to cardiopulmonary bypass

Secondary Outcome Measures:
  • neuropsychological tests

Estimated Enrollment: 200
Study Start Date: February 2006
Estimated Study Completion Date: May 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00297245

Contacts
Contact: Shihai Zhang, M.D.,Ph.D. 862-785-726-834 zhangshh@public.wh.hb.cn
Contact: Shihai Zhang, M.D., Ph.D. 862-785-726-834 zhangshh@public.wh.hb.cn

Locations
China, Hubei
Department of Anesthesiology, Union Hospital Recruiting
Wuhan, Hubei, China, 430022
Contact: Shihai Zhang, M.D., Ph.D.    862-785-726-834    zhangshh@public.wh.hb.cn   
Principal Investigator: Shihai Zhang, M.D., Ph.D.         
Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
Principal Investigator: Shihai Zhang Department of Anesthesiology, Union Hosiptal, Tongji Medical College, Huazhong University of Science and Technology
Principal Investigator: Shihai Zhang, M.D., Ph.D. Department of Anesthesiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00297245     History of Changes
Other Study ID Numbers: 21124941
Study First Received: February 27, 2006
Last Updated: February 27, 2006
Health Authority: China: Ministry of Health

Keywords provided by Huazhong University of Science and Technology:
gastrodin

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014