NCT00297245

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 28, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

February 28, 2006

Status Verified

January 1, 2006

First QC Date

February 27, 2006

Last Update Submit

February 27, 2006

Conditions

Keywords

gastrodin

Outcome Measures

Primary Outcomes (1)

  • Gastrodin markedly prevents cognitive decline related to cardiopulmonary bypass

Secondary Outcomes (1)

  • neuropsychological tests

Interventions

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients undergo mitral valve replacement surgery.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Union Hospital

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

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

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 27, 2006

First Posted

February 28, 2006

Study Start

February 1, 2006

Study Completion

May 1, 2006

Last Updated

February 28, 2006

Record last verified: 2006-01

Locations