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The effect of intravenous selenium on stress oxidative in ARDS patients in intensive care units

Protocol summary

Summary
Objectives: 1- Determining the effects of intravenous Selenium on reducing mechanical ventilation period in ARDS patients; 2-Determining the effects of intravenous Selenium on the duration of hospitalization of ARDS patients in intensive care unit (ICU); 3- Determining the effects of intravenous Selenium on discontinuing treatment with vasopressors in ARDS patients in ICU; 4- Determining the effects of intravenous Selenium on end-organ damage parameters (SOFA) in ARDS patients in ICU Design: study groups: This study will be conducted as a randomized clinical trial.Patients will be divided into two groups of treatment with intravenous selenium and placebo; sample size: 40; Blinding: not-blinded; randomization: patients will be divided into two groups, randomly, using Gravtron 2.0 software; Centers: it was a two-centered study, conducted in Shohada and Imam Reza hospitals; Phase: Not Applicable Setting and conduct: Group A patients will receive intravenous Selenium for 10 days, and Group B patients will receive the same amount of placebo. From all patients, on days 0, 7, and 14 blood samples will be obtained to evaluate the antioxidant status, using glutathione peroxidase kits (TRAP and FRAP). Demographic characteristics, duration of mechanical ventilation, length of hospitalization in ICU, duration of receiving vasopressors, mechanical Indices, Arterial blood gas parameters, SOFA (Sequential Organ Failure Assessment), causes of ICU hospitalization, mortality and receiving fluids will be recorded. Major inclusion criteria: patients above 18 years; asymmetric and diffused involvemnet of lungs in chest X-ray; lung involvement less than a week; proportion of arterial oxygen pressure (Pao2) to Fio2 more than 200; Exclusion criteria: hypersensitivity to Selenium; pregnancy and lactation; renal failure Intervention: Intravenous Selenium Primary outcome measures: Ventilation free days, oxidative stress status (based on Glutathione peroxidase) Secondary outcome measures: Vasopressor free days

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201706172582N17
Registration date: 2017-09-12, 1396/06/21
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-09-12, 1396/06/21
Registrant information
Name
Ata Mahmoodpoor
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 116 0888
Email address
mahmoodpoora@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2017-10-01, 1396/07/09
Expected recruitment end date
2018-06-01, 1397/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intravenous selenium on stress oxidative in ARDS patients in intensive care units
Public title
The effect of intravenous selenium on stress oxidative in Acute Respiratory Distress Syndrome (ARDS) patients in intensive care units
Purpose
Treatment
Inclusion/Exclusion criteria
Major inclusion criteria: patients above 18 years; asymmetric and diffused involvemnet of lungs in chest X-ray; lung involvement less than a week; proportion of arterial oxygen pressure (Pao2) to Fio2 more than 200; Exclusion criteria: hypersensitivity to Selenium; pregnancy and lactation; renal failure
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Postal code
Approval date
2017-07-03, 1396/04/12
Ethics committee reference number
IR.TBZMED.REC.1396.277

Health conditions studied

1

Description of health condition studied
Acute respiratory distress syndrome
ICD-10 code
j80
ICD-10 code description
Adult respiratory distress syndrome

Primary outcomes

1

Description
oxidative stress status(gluthatione peroxidase)
Timepoint
One day before the intervention. Seven days after intervention. Fourteen days after the intervention
Method of measurement
using FRAP and TRAP kits

2

Description
ventilation free days
Timepoint
number of days that patients do not require mechanical ventilation, within the 14 days of study period
Method of measurement
with counting the ventilation free days and recording them in forms

Secondary outcomes

1

Description
vasopressor free days
Timepoint
number of days that patients do not require vasopressor administration, within the 14 days of study period
Method of measurement
with counting vasopressor free days and recording them in forms

Intervention groups

1

Description
intervention group 1: these patients will be administered with 4 mg of intravenous selenase (produced by Biosyn company, Germany). Then, for 3 days the will receive 1mg/12h then for the last 10 days they will be injected by 1mg/day of it.
Category
Treatment - Drugs

2

Description
Control group 1: they will receive placebo with the exact same doses.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada Hospital
Full name of responsible person
ِDr Ata Mahmoodpoor
Street address
Golshahr street, El-goli freeway
City
Tabriz

2

Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Dr Ata Mahmoodpoor
Street address
Golgasht street
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostadrahimi
Street address
Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
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, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr Zohreh Ostadi
Position
sub-specialty fellowship of intensive care medicine
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Postal code
Phone
+98 914 414 6027
Fax
Email
Zohreh_ostadi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Ata Mahmoodpoor
Position
Anesthesiologist
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Postal code
Phone
+98 41333893336
Fax
Email
mahmoodpoora@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Zohre Ostadi
Position
intensive care medicine fellowship
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Postal code
00984133364324
Phone
+98 41 3336 4324
Fax
Email
zohreh_ostadi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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