IRCT201212082887N4 IRCT 2014-08-29 Vice chancellor for research, Tehran University of Medical Sciences The effects of high dose of selenium in the treatment of patient with severe sepsis The effect of high dose of selenium in mortality of patient with severe sepsis 2012-02-01 anticipated 51 Complete https://irct.ir/trial/2760 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Before the beginning of the study by software the numbers of patients are randomly divided into 2 groups. With the arrival of each patient the cards are open for patient that the groups of patient are diagnosed. 2-3 Severe sepsis. Intervention 1: One the first day study, begining 2000 microgram selenium boluses (in 1 hour) then 1500 microgram selenium 24 hour infusion for 14 days in 50 milliliter sodium chloride solution. Intervention 2: The standard treatment for sepsis without prescription selenium.

public Arezoo Ahmadi

Sina Hospital, Emam Khomeini Street, Hasan abad Square, Tehran

Tehran Iran (Islamic Republic of) +98 21 6634 8500 aarezoo24@gmail.com Sina Hospital scientific Arezoo Ahmadi

Sina Hospital, Emam Khomeini Street, Hasan abad Square, Tehran

Tehran Iran (Islamic Republic of) +98 21 6634 8500 Aarezoo24@gmail.com Sina Hospital Iran (Islamic Republic of) Inclusion criteria: Patient with suspected or documented diagnosis of infection with at least one of these: White blood cell (WBC) in sterile regions, Perforated viscera; Radiologic evidence of pneumonia and infected sputum; High risk infection such as Cholangitis; and at least three of the following: Body temperature above 38 degrees Celsius or under 36; Heart rate greater than 90 beat per minute without consuming any medication, Respiratory rate more than 20 per minute or arterial pressure of carbon dioxide less than 32 millimeter of mercury with mechanical ventilation; White blood cells more than 12000 or less than 1000; more than 10 percent band Neutrophils. Exclusion criteria: more than 24 hours of diagnosis of sever sepsis; high probability death due to a nonspecific cause (renal insufficiency, hepatic encephalopathy, etc) within the first 28 days; pregnancy or lactating; Age less than 16 years; dissatisfaction of patient or his family to enter the study; patients with Cancer 17 years 90 years Both R65.1 Systemic Inflammatory Response Syndrome of infectious origin with organ failure Severe sepsis Treatment - Drugs Other One the first day study, begining 2000 microgram selenium boluses (in 1 hour) then 1500 microgram selenium 24 hour infusion for 14 days in 50 milliliter sodium chloride solution. The standard treatment for sepsis without prescription selenium Mortality. Timepoint: Mortality within 28 days of after diagnosis with severe sepsis. Method of measurement: Counting the number of patient died. Length of ICU stay. Timepoint: Number of bed days in ICU since entry into the research. Method of measurement: Registration for beding in ICU. Level of Super Oxide Dismutase. Timepoint: Base line and day 3, 7, 10, 14 after prescription. Method of measurement: measuring enzyme concentration in the blood. MMP (Matrix Metalloproteinase). Timepoint: Baseline and day 3, 7, 10, 14 after treatment with selenium. Method of measurement: measuring the enzyme concentration in the blood. PAF (Platelet-activating factor). Timepoint: Baseline and day 3, 7, 10, 14 days after treatments with selenium. Method of measurement: measuring the concentration of PAF in the blood. Total anti oxidant power. Timepoint: Baseline and day 3, 7, 10, 14 after treatments with selenium. Method of measurement: measuring Anti-oxidant power concentration in the blood. Interleukin 1. Timepoint: Baseline and day 3, 7, 10, 14 after treatments with selenium. Method of measurement: measuring IL-1 concentration in the blood. TGF (Transforming Growth Factor). Timepoint: Baseline and day 3, 7, 10, 14 after treatment with selenium. Method of measurement: measuring TGF concentration in the blood. SOFA Score (Simplified Acute Physiology Score). Timepoint: Baseline and day 3, 7, 10, 14 after treatments with selenium. Method of measurement: Calculation. APACHI II Score (Acute Physiology and Chronic Health Evaluation II). Timepoint: Baseline and day 3, 7, 10, 14 after treatment with selenium. Method of measurement: Calculation. NGAL (Neutrophil Gelatinase Associated Lipocalin). Timepoint: Baseline and day 3, 7, 10, 14 after treatment with selenium. Method of measurement: measuring NGAL concentration in the blood. Vice chancellor for research, Tehran University of Medical Sciences Approved 2011-06-19 Research center of Science Tehran University of Medical sciences Old building's School of Pharmacy, Tehran University of Medical Sciences Tehran Iran (Islamic Republic of)