Gastrodin prevents cognitive decline related to cardiopulmonary bypass
| ISRCTN | ISRCTN47168298 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47168298 |
| ClinicalTrials.gov (NCT) | NCT00297245 |
| Protocol serial number | FWA00007304 |
| Sponsor | Tongji Medical College (China) |
| Funder | Supported by Grant (30271255) from the National Science Foundation of China. |
- Submission date
- 25/02/2006
- Registration date
- 25/04/2006
- Last edited
- 11/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Shihai Zhang
Scientific
Scientific
1277 Jiefang Street
Wuhan
430022
China
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind, randomized controlled study |
| Secondary study design | Randomised controlled trial |
| Scientific title | Gastrodin prevents cognitive decline related to cardiopulmonary bypass |
| Study objectives | Cardiopulmonary bypass (CPB) is associated with significant cerebral morbidity. The incidence of cognitive decline related to CPB ranges from 20% to 80%. However, there is no effective method to prevent the decline. 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. |
| Ethics approval(s) | Approved by the Ethics Committee at Tongji Medical College on 19/01/2006, reference number: FWA00007304 |
| Health condition(s) or problem(s) studied | Neurocognitive decline related to CPB |
| Intervention | Patients are randomized to receive either one the following interventions: 1. Gastrodin (40 mg/kg in 50 ml saline) will be injected intravenously with a pump within 45 minutes after induction of anesthesia 2. Saline 50 ml will be injected intravenously with a pump within 45 minutes after induction of anesthesia |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Gastrodin |
| Primary outcome measure(s) |
Neurocognitive function |
| Key secondary outcome measure(s) |
Safety of gastrodin |
| Completion date | 01/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Total final enrolment | 200 |
| Key inclusion criteria | Adult patients (18 to 65 years) that have undergone mitral valve replacement surgery |
| Key exclusion criteria | 1. Patients who have thrombosis in left atrium 2. A history of symptomatic cerebrovascular disease 3. Diabetes 4. Psychiatric illness 5. Renal disease or active liver disease 6. Less than a seven-grade education or those who cannot read will be excluded |
| Date of first enrolment | 01/03/2006 |
| Date of final enrolment | 01/06/2006 |
Locations
Countries of recruitment
- China
Study participating centre
1277 Jiefang Street
Wuhan
430022
China
430022
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2011 | 11/01/2021 | Yes | No |
Editorial Notes
11/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NCT numbers has been added.
