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IRCT20201109049317N1 IRCT 2021-05-03 Kerman University of Medical Sciences Effect of selenium and n-acethylcysteine antioxidants on superoxide dismutase enzyme. Comparison of the average superoxide dismutase enzyme in the groups receiving selenium and n-acethylcysteine antioxidants in severe trauma patients admitted to an intensive care unit 2019-08-05 anticipated 60 Complete https://irct.ir/trial/52309 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After determination of the sample size by block randomization method patients divided into three groups of twenty patients (2 patientes in the case group1and 2 patients in case group 2 and 2 patients in control group) Based on the time of patient entrance, patients divided into groups consist of 6patients then accidentaly each group divided into 3 sub group.To do randomization all ABC cases (AABBCC,ABCABC....)are considered.Then we put them on the envelopes and we arrange 6 groups of envelopes ,in each group, the group name was repeated 2 times.After evaluation of inclusion and exclusion criteria the selected patient or his family choose the pocket and the group. To blind patients and researchers ,the groups are placed in an envelope in the form of ABC.This process repeated for each patient to obtain the final sample size , Blinding description: As the color and the shape of the drugs are the same, The patients did not know whic drugs they are getting . 4 Sever Trauma. Intervention 1: Intervention group: Selanase vial 50 mcg in 10 cc.FIRST.Receive selenium in first day 1000 mcg over 24 hours.second day 400 mcg over24 hours.third day 200 mcg over24 hours. Intervention 2: Control group:Recieve Placebo=2fi00 cc normal saline over 24 hours for 3 days. Intervention 3: Intervention group: Second.Recive N.Acetylcystein20% vial=first day 300mg per kilogram over 24 hours.second day 150mg per kilogram over 24 hours.third day 75 mg per kilogram over 24 hours. Yes - There is a plan to make this available What will be shared: Information will be available after publishing. When: 6 to 12 months To whom: All of researcher Conditions: Person who research on patients admitted in intensive care units. Where to obtain: Validated scientific journals How to obtain: Search in valid article Comments:
public Leili Asadabadi
No64.16 cross.shafa Ave
Kerman Iran (Islamic Republic of) 7618745477 +98 34 3211 8067 lasadabadi@yahoo.com Kerman University of Medical Sciences scientific Leili Asadabadi
No.64, 16th cross, Shafa street, Kerman, Iran
Kerman Iran (Islamic Republic of) 7618745477 +98 34 3211 8067 asadabadi.l@vums.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Age older than 18 year Severe trauma patients need to admit in an Intensive Care Unit 18 years no limit Both Incomplete demographic information Preexisting conditions Sepsis and organ failure Drug sensitivity Treatment - Drugs Placebo Treatment - Drugs Intervention group: Selanase vial 50 mcg in 10 cc.FIRST.Receive selenium in first day 1000 mcg over 24 hours.second day 400 mcg over24 hours.third day 200 mcg over24 hours. Control group:Recieve Placebo=2fi00 cc normal saline over 24 hours for 3 days. Intervention group: Second.Recive N.Acetylcystein20% vial=first day 300mg per kilogram over 24 hours.second day 150mg per kilogram over 24 hours.third day 75 mg per kilogram over 24 hours. Superoxide dismutase. Timepoint: 3 days after drug infusion. Method of measurement: Superoxide Dismutase Assay Kit. Organ function. Timepoint: 3 days after drug infusion. Method of measurement: APACHI 2. Level of concsiousness. Timepoint: 3days after drug infusion. Method of measurement: Glasco Coma Scale. Duration of hospitalization. Timepoint: Days of hospitalization after drug infusion. Method of measurement: Days of hospitalization. Kerman University of Medical Sciences Approved 2019-08-13 Ethic committee of Kerman University of Medical Sciences Emam Highway.Afzalipour Hospital kerman Kerman Iran (Islamic Republic of)