This study is a prospective observational study that is going to be conducted at General and Emergency ICUs of Sina hospital and Internal ICU of Imam Khomeini hospital.25 adult patients with subarachnoid hemorrhage; GCS ≤ 12 will be taken valproic acid as a seizure prophylactic agent for seven days.Patients who have seizure during the study will excluded. We consider 1200 mg intravenous sodium valproate as a loading dose that will be diluted in at least 50 ml of normal saline solution and will be infused over 60 minutes with a maximum speed of 20 mg/min and then the patients will taken 400 mg intravenous sodium valproate Q8h for three days and then the patients will taken 500 mg sodium valproate orally for other four days Q8h. Patients will be studied for a week and blood Samples will be collected after 4 hours, 12 hours, before the third dose ,before the XII dose and before the last dose. Immediately after sampling,the blood samples will be centrifuged for 10 minutes (3000rpm/min) to collect plasma .Serum samples will be maintained at - 80 ° C until analysing time.Analysis of serum samples containing valproic acid will be conducted by GC-MASS (Gas chromatography–mass spectrometry ) method.The pharmacokinetic key parameters of the drug include the volume of distribution, plasma concentraion ,clearance and main metabolites of the drug( 2-ene-valproate and 4-ene valproate) will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013091113572N3
Registration date:2013-09-22, 1392/06/31
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-09-22, 1392/06/31
Registrant information
Name
Mohammadreza Rouini
Name of organization / entity
Tehran University of Medical Sciences, Faculty of Pharmacy
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 9056
Email address
rouini@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
1-Financial supporting from Tehran University of Medical Sciences-accepted as an university scientific project
2-Providing all medicine by coble darou that related to Sanofi aventis pharmaceutical company
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Evaluation of Valproic acid Pharmacokinetic Key Parameters as a Seizure Prophylactic Agent Following Subarachnoid Hemorrhage
Public title
Evaluation the serum level of valproic acid in subarachnoid hemorrhage patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients with subarachnoid hemorrhage; GCS ≤ 12; Age over 18
Exclusion Criteria: Scr≤1.5 mg/dl or urine output>0.5cc/Kg/hr; Plattlet count<100,000; INR≥2; Albumin<3; Age >18; Liver Function Test>3×Normal Range; Mean Arterial Pressure<70; Occurance of seizure during the study; Previous CNS diseases such as Parkinson's, Multiple sclerosis, CNS tumors, Infections involving the brain and CNS; History of using anti-epileptic drugs; Pregnancy; History of urea cycle disorders
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Ghods st, Enghelab st, Tehran, Ethical Committee of Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2013-06-16, 1392/03/26
Ethics committee reference number
91-04-33-20322
Health conditions studied
1
Description of health condition studied
subarachnoid hemorrhage
ICD-10 code
160
ICD-10 code description
ruptured cerebral aneurysm
Primary outcomes
1
Description
Total serum concentration
Timepoint
after 4 hours, 12 hours, before the third dose ,before the XII dose and before the last dose
Method of measurement
blood sampling from cv-line/GS-MASS
Secondary outcomes
1
Description
unbound serum concentration
Timepoint
after 4 hours, 12 hours, before the third dose ,before the XII dose and before the last dose
Method of measurement
formula
2
Description
volume of distribution
Timepoint
after 4 hours, 12 hours, before the third dose ,before the XII dose and before the last dose
Method of measurement
formula
3
Description
clearance
Timepoint
after 4 hours, 12 hours, before the third dose ,before the XII dose and before the last dose
Method of measurement
formula
4
Description
2-ene-valproate as a metabolite
Timepoint
after 4 hours, 12 hours, before the third dose ,before the XII dose and before the last dose
Method of measurement
GS-MASS
5
Description
4-ene-valproate as a metabolit
Timepoint
after 4 hours, 12 hours, before the third dose ,before the XII dose and before the last dose
Method of measurement
GS-MASS
Intervention groups
1
Description
we consider 1200 mg intravenous sodium valproate as a loading dose that will be diluted in at least 50 ml of normal saline solution and will be infused over 60 minutes with a maximum speed of 20 mg/min and then the patients will taken 400 mg intravenous sodium valproate Q8h for three days and then the patients will taken 500 mg sodium valproate orally for other four days Q8h. Patients will be studied for a week and blood Samples will be collected after 4 hours, 12 hours, before the third dose ,before the XII dose and before the last dose
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency and General ICU of Sina Hospital
Full name of responsible person
Dr.Mojtaba Mojtahedzadeh
Street address
Sina Hospital, Hasanabad square, Emam Khomeini st, Tehran
City
Tehran
2
Recruitment center
Name of recruitment center
General ICU of Emam Khomeini Hospital
Full name of responsible person
Dr.Mohammadtaghi Beyg Mohammadi
Street address
Emam Khomeini Hospital, Bolvar Keshavarz st, Valiasr square, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University Of Medical Sciences
Full name of responsible person
Dr.Mohammad Sharifzadeh
Street address
Faculty of Pharmacy, Tehran University of Medical Sciences, Ghods st, Enghelab st, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University Of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Cobel Darou Company
Full name of responsible person
Dr.Shokrollah Memarian
Street address
39, Alvand st, Arzhantin square, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Cobel Darou Company
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University Of Medical Sciences
Full name of responsible person
Dr.Mohammadreza Rouini
Position
Full Professor
Other areas of specialty/work
Street address
Pharmaceuitics Department, Faculty of Pharmacy, Tehran University of Medical Sciences, Ghods st, Enghelab st, Tehran
City
Tehran
Postal code
Phone
+98 21 6695 9056
Fax
Email
rouini@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Mojtaba Mojtahedzadeh
Position
full professor
Other areas of specialty/work
Street address
Clinical Pharmacy Department, Faculty of Pharmacy, Tehran University of Medical Sciences, Ghods st, Enghelab st
City
Tehran
Postal code
Phone
+98 912 105 6032
Fax
Email
mojtahed@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Mohammadreza Rouini
Position
Full professor
Other areas of specialty/work
Street address
Pharmaceuitics Department, Faculty of Pharmacy, Tehran University of Medical Sciences, Ghods st, Enghelab st, Tehran
City
Tehran
Postal code
Phone
+98 21 6695 9056
Fax
Email
rouini@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)