This study is a randomized controlled clinical trial that include 51 adult patients suffering from severe sepsis with Acute Physiology and Chronic Health Evaluation II score (APACHE II) above 12, admitted to intensive Care Unit (ICU) of Sina hospital. Patients will be randomly divided into 2 groups: one group will receive standard treatment for sepsis according to SSC, another group will receive standard treatment for sepsis plus high dose of Selenium. All patients will have CV line. Biomarkers will be measured in the following days 1, 3, 5, 7, 10, and 14. On the first day of the study, the patients in Selenium group will receive 2000 micrograms Selenium as bolus dose during an hour followed by 1500 micrograms Selenium in 50 milliliter normal saline as 24-hour infusions for 14 days. We will follow the patients' mortality from all causes up to 28 days.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212082887N4
Registration date:2014-08-29, 1393/06/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-29, 1393/06/07
Registrant information
Name
mojtaba mojtahedzadeh
Name of organization / entity
pharmacy school of tehran university of medical science
Country
Iran (Islamic Republic of)
Phone
02166735168-02164122209
Email address
mojtahed@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2012-02-01, 1390/11/12
Expected recruitment end date
2014-02-01, 1392/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of high dose of selenium in mortality of patient with severe sepsis
Public title
The effects of high dose of selenium in the treatment of patient with severe sepsis
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 17 years old to 90 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
51
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
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.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research center of Science Tehran University of Medical sciences
Street address
Old building's School of Pharmacy, Tehran University of Medical Sciences
City
Tehran
Postal code
1417614411
Approval date
2011-06-19, 1390/03/29
Ethics committee reference number
(1-1: 90-3-29)
Health conditions studied
1
Description of health condition studied
Severe sepsis
ICD-10 code
R65.1
ICD-10 code description
Systemic Inflammatory Response Syndrome of infectious origin with organ failure Severe sepsis
Primary outcomes
1
Description
Mortality
Timepoint
Mortality within 28 days of after diagnosis with severe sepsis
Method of measurement
Counting the number of patient died
2
Description
Length of ICU stay
Timepoint
Number of bed days in ICU since entry into the research
Method of measurement
Registration for beding in ICU
Secondary outcomes
1
Description
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
2
Description
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
3
Description
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
4
Description
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
5
Description
Interleukin 1
Timepoint
Baseline and day 3, 7, 10, 14 after treatments with selenium
Method of measurement
measuring IL-1 concentration in the blood
6
Description
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
7
Description
SOFA Score (Simplified Acute Physiology Score)
Timepoint
Baseline and day 3, 7, 10, 14 after treatments with selenium
Method of measurement
Calculation
8
Description
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
9
Description
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
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
The standard treatment for sepsis without prescription selenium
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Aarezoo Ahmadi
Street address
Sina Hospital, Emam Khomeini Street, Hasan abad Square, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Ms.Saidi
Street address
Tehran University of Medical Sciences- Vice chancellor for research- Keshavarz blvd corner- Ghods street-Enghelab avenue
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
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
Sina Hospital
Full name of responsible person
Arezoo Ahmadi
Position
Critical Care Fellowship
Other areas of specialty/work
Street address
Sina Hospital, Emam Khomeini Street, Hasan abad Square, Tehran
City
Tehran
Postal code
Phone
+98 21 6634 8500
Fax
Email
aarezoo24@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sina Hospital
Full name of responsible person
Arezoo Ahmadi
Position
Critical Care Fellowship
Other areas of specialty/work
Street address
Sina Hospital, Emam Khomeini Street, Hasan abad Square, Tehran
City
Tehran
Postal code
Phone
+98 21 6634 8500
Fax
Email
Aarezoo24@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sina Hospital
Full name of responsible person
Arezoo Ahmadi
Position
Critical Care Fellowship
Other areas of specialty/work
Street address
Sina Hospital, Emam Khomeini Street, Hasan abad Square, Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)