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Gastrodin Prevents Cognitive Decline Related to Cardiopulmonary Bypass

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ClinicalTrials.gov Identifier: NCT00297245
Recruitment Status : Unknown
Verified January 2006 by Huazhong University of Science and Technology.
Recruitment status was:  Recruiting
First Posted : February 28, 2006
Last Update Posted : February 28, 2006
Sponsor:
Information provided by:
Huazhong University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Cognitive Decline Drug: cognitive function Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Study Start Date : February 2006
Study Completion Date : May 2006



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

Secondary Outcome Measures :
  1. neuropsychological tests


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00297245     History of Changes
Other Study ID Numbers: 21124941
First Posted: February 28, 2006    Key Record Dates
Last Update Posted: February 28, 2006
Last Verified: January 2006

Keywords provided by Huazhong University of Science and Technology:
gastrodin

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders