Evaluating the nueroprotective effect of memantine during cardiopulmonary bypass
Design
In this interventional study, we will investigate the release of S100B Protein with the consent of patients and explanations about the process of the drug prescribing. Patients will be divided into two groups. The control group will not receive placebo. The second group will receive memantine at a dose of 10 mg / bid within 3 days before surgery. The first blood sample will be taken from the patient before surgery, and the next samples will be taken after cardiopulmonary bypass (CPB) weaning, 6 hours and 24 hours post-operatively to measure plasma S100B.
Settings and conduct
This study will be conducted in Mazandaran Heart Center. Prescribing of the memantine will be done in the preoperative period and the samples will be sent to the laboratory at the appointed time. Blinding will be performed for the surgeon and laboratory staff, and the patient will be followed up to evaluate the tests through the file number.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients that are candidate for open heart surgery
Age between 18 to 80 years
Exclusion criteria:
Acute or chronic renal or hepatic failure
History of memantine consumption within last 6 months
History of neurological disorders
Intervention groups
Intervention group: memantine 10 mg/bid for 3 days before surgery
Control group: will not receive any medication or placebo
Main outcome variables
S100B levels
Occurrence of neurological deficit after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200502047276N1
Registration date:2020-06-02, 1399/03/13
Registration timing:prospective
Last update:2020-06-02, 1399/03/13
Update count:0
Registration date
2020-06-02, 1399/03/13
Registrant information
Name
Alireza Sanei Motlagh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3331 4755
Email address
alireza.scts@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The neuroprotective effect of memantine during cardiopulmonary bypass in patients that are candidate for cardiac surgery
Public title
The neuroprotective effect of memantine during cardiopulmonary bypass
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients that are candidate for open heart surgery
Age between 18 to 80 years
Exclusion criteria:
Acute or chronic renal failure (AKI stage 4 or 5)
Creatinine clearance less than 30 ml/min
Moderate to severe hepatic failure
Autoimmune disease
Alzheimer or dementia
History of memantine consumption within last 6 months
History of seizure, CVA, or psychiatric disorders