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IRCT2013091113572N3 IRCT 2013-09-22 Tehran University Of Medical Sciences Evaluation the serum level of valproic acid in subarachnoid hemorrhage patients The Evaluation of Valproic acid Pharmacokinetic Key Parameters as a Seizure Prophylactic Agent Following Subarachnoid Hemorrhage 2013-09-23 anticipated 25 Complete https://irct.ir/trial/13405 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention. N/A subarachnoid hemorrhage. 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.
public Dr.Mohammadreza Rouini
Pharmaceuitics Department, Faculty of Pharmacy, Tehran University of Medical Sciences, Ghods st, Enghelab st, Tehran
Tehran Iran (Islamic Republic of) +98 21 6695 9056 rouini@tums.ac.ir Tehran University Of Medical Sciences scientific Dr.Mojtaba Mojtahedzadeh
Clinical Pharmacy Department, Faculty of Pharmacy, Tehran University of Medical Sciences, Ghods st, Enghelab st
Tehran Iran (Islamic Republic of) +98 912 105 6032 mojtahed@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years 100 years Both 160 ruptured cerebral aneurysm Prevention 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 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. 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. 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. Clearance. Timepoint: after 4 hours, 12 hours, before the third dose ,before the XII dose and before the last dose. Method of measurement: formula. 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. 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. Cobel Darou Company Tehran University Of Medical Sciences Cobel Darou Company Approved 2013-06-16 Ethical Committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Ghods st, Enghelab st, Tehran, Ethical Committee of Tehran University of Medical Sciences Tehran Iran (Islamic Republic of)