Determining the effect of selenium administration on complete blood count (CBC) in the elderly admitted to the intensive care unit
Design
A double-blind randomized clinical trial with two groups: Selenium and control group
Settings and conduct
The study will be conducted at Imam Reza and Shohada Hospital. Patients will be randomly divided into two groups of selenium, and Selin by the block method. The researchers and participants will not be aware of the groups involved.
Participants/Inclusion and exclusion criteria
Patients over 60 years admitted to the intensive care unit of Shohada and Imam Reza Hospital with an APACHE II score above 15 will be included in the study. Exclusion criteria include a history of malignancy, Renal failure, and Suppression of the immune system
Intervention groups
Selenium group will receive bolus administration of selenium (3000 µg) for 3 hours in the beginning, and then they will receive 1500 µg /day for one hour for 10 days. Patients in the control group will receive normal saline for 10 days.
Main outcome variables
Platelet amount that will be checked with complete blood count.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091012002582N23
Registration date:2021-05-18, 1400/02/28
Registration timing:prospective
Last update:2021-05-18, 1400/02/28
Update count:0
Registration date
2021-05-18, 1400/02/28
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
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2022-06-05, 1401/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of selenium administration on complete blood count in elderly patients admitted to critical care unit
Public title
The effect of selenium administration on complete blood count in elderly patients admitted to critical care unit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients above 60 years admitted to critical care unit
APACHE II above 15
Exclusion criteria:
History of malignancy
Renal failure
Suppression of the immune system
Age
From 60 years old to 100 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Initially, the blocks (n=4) with different arrangements of A and B will be defined. Considering the different probable arrangements of A and B, blocks will be numbered from 1 to 6. To enroll the initial 4 patients into the study, one of the arrangements will be selected using the random digit table and the patients will be assigned into the A and B groups accordingly. For the next 4 patients, the arrangement pattern will be selected again and the patients will be assigned to the groups and this cycle will be repeated to achieve our intended sample size. The unpredictability of assignment and balancing the number of patients across the two groups during or at the end of the study are the main advantages of this method. Notably, the patients will be assigned into the study based on the ICU date of admission and nobody will be able to assign the patients to the specific group of interest.
Blinding (investigator's opinion)
Double blinded
Blinding description
The aim of double-blinding is the avoidance of patients and researchers from being informed about the study intervention, so enrollment of patients in groups will not be recognized. The patients will be assigned into the study based on the ICU date of admission and determined series by randomization process ( based on blocks) and the researcher will not be aware of the patient's assignment in the intervention and control groups. The informed consent will be obtained from the patient's next of kin and they will thoroughly be informed about the study but they will be blind about the group in which their patient will be included.
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
Golgasht street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2021-02-22, 1399/12/04
Ethics committee reference number
IR.TBZMED.REC.1399.1076
Health conditions studied
1
Description of health condition studied
Other infectious disease
ICD-10 code
B99.8
ICD-10 code description
Other infectious disease
Primary outcomes
1
Description
platelet
Timepoint
days 1th and 10th
Method of measurement
Complete blood count
Secondary outcomes
1
Description
Red Cell Distribution Width
Timepoint
Days 1th and 10th
Method of measurement
Complete blood count
2
Description
The ratio of neutrophils to lymphocytes
Timepoint
Days 1th and 10th
Method of measurement
Complete blood count
Intervention groups
1
Description
Intervention group: Patients in the intervention group will receive bollus administraion of IV selenium (3000 µg) (produced by Biosyn company, Germany) during 3 hours at the beginning, and then they will receive 1500 µg /day during one hour for 10 days
Category
Treatment - Drugs
2
Description
Control group: Patients in control group will receive normal saline as the same volume and speed for 10 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada hospital, ICU
Full name of responsible person
Ata Mahmoodpoor
Street address
ICU, Shohada hospital, El-Goli street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4667
Email
research-vice@tbzmed.ac.ir
2
Recruitment center
Name of recruitment center
General ICU of Imam Reza hospital
Full name of responsible person
Ata Mahmoodpoor
Street address
General ICU, Imam Reza hospital, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4667
Email
research-vice@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
Golgasht street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 4280
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ata Mahmoodpoor
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Golgasht street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4667
Email
amahmoodpoor@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ata Mahmoodpoor
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Faculty of Medicine, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4667
Email
amahmoodpoor@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sarvin Sanaie
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 2178
Email
sarvin_so2000@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD