Determining the effect of high doses of selenium in patients undergoing coronary artery bypass surgery
Design
A clinical trial with a control group, with parallel groups. No blinding. Phase 3 was randomized on 70 patients and balanced block was used for randomization.
Settings and conduct
It is an interventional and randomized controlled clinical trial study. The sample size is 70 people. They were referred to the heart surgery room of Shahid Beheshti Hospital, Qom, and after obtaining written consent, they were divided into two groups by randomization using the block randomization method:
The first group: they receive a vial of 500 micrograms of selenium (manufactured by BIOSYN, Germany) before induction of anesthesia, a vial of 500 micrograms of selenium before transfer to the cardiopulmonary bypass pump, and finally a vial of 500 micrograms of selenium after Transfer the patient to the cardiopulmonary bypass pump.
The second group: They receive normal saline at the same time as the first group, that is, before the induction of anesthesia, before transfer to the cardiopulmonary bypass pump and after transfer to the cardiopulmonary bypass pump.
Participants/Inclusion and exclusion criteria
Inclusion: age over 15 years; no history of allergy to selenium; candidate patients for on-pump CABG
Exclusion : Sensitization to selenium, pregnancy, history of coagulation disorders
Emergency surgery
Off-pump CABG
The presence of chronic diseases such as: patients with kidney dysfunction, patients with liver dysfunction,
Patients with thyroid disorders
Intervention groups
The first group received high dose selenium and the second group received placebo (normal saline serum).
Main outcome variables
Clinical status
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20220614055165N1
Registration date:2023-07-18, 1402/04/27
Registration timing:prospective
Last update:2023-07-18, 1402/04/27
Update count:0
Registration date
2023-07-18, 1402/04/27
Registrant information
Name
mohammad saeidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3612 2000
Email address
dr.msaeidi@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of high dose of selenium on the Clinical Situation of patients undergoing coronary artery bypass surgery with a pump
Public title
Investigation of the effect of selenium on the treatment of patients undergoing coronary artery bypass surgery with a pump
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patients on-pomp with Coronary artery bypass graft surgery
Exclusion criteria:
Patients under Off- pomp Coronary artery bypass graft surgery
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
This study will be performed by a random sampling method, block allocation. In such a way that In this study, 60 patients with corona will be randomly divided into two groups. The selection of groups will be based on the fact that individuals will be assigned to groups based on block randomization. Block size 4 is considered. So we have six blocks of four, ABAB, ABBA, AABB, BAAB BBAA, and BABA. The selection of each block will also be random and will be done using dice. For example, if the number 5 comes in the dice roll, the AABB block is considered Therefore, the first two patients are assigned to treatment A, and the two patients are then assigned to treatment B. The dice will be thrown ten times to complete the allocation of patients to treatment groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
Street address
No. 83, Shahid Lotfi Niaser Ave, Safashehr Blvd
City
Qom
Province
Ghoum
Postal code
3719964797
Approval date
2022-05-10, 1401/02/20
Ethics committee reference number
IR.MUQ.REC.1401.054
Health conditions studied
1
Description of health condition studied
Coronary Artery Bypass Graft Surgery
ICD-10 code
T82.218D
ICD-10 code description
Other mechanical complication of coronary artery bypass graft, subsequent encounter
Primary outcomes
1
Description
Clinical Situation
Timepoint
Before the start of the intervention, during the intervention
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One vial of 500 micrograms of selenium {BIOSYN manufacturer, made in Germany} before anesthesia induction, one vial of 500 micrograms of selenium before transfer to the cardiopulmonary bypass pump and one vial of 500 micrograms of selenium after transferring the patient to the cardiopulmonary bypass pump.
Category
Treatment - Drugs
2
Description
Control group: Control group: normal saline serum at the same time as the first group, i.e. before induction of anesthesia, before transfer to cardiopulmonary bypass pump and after transfer to cardiopulmonary bypass pump.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital
Full name of responsible person
Mohammad Saedi
Street address
Beheshti Hospital, Beheshti Blvd, Qom, Iran
City
QOM
Province
Ghoum
Postal code
37719964797
Phone
+98 25 3612 2000
Email
dr.msaeidi@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Rahim Aali
Street address
No. 83, Shahid Lotfi Niaser Ave, Safashehr Blvd
City
qom
Province
Ghoum
Postal code
93456-37169
Phone
+98 25 3285 4011
Email
rahimalii@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Moahmmad Saeidi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Beheshti Hospital, Beheshti Blvd, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Email
dr.msaeidi@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mohammad Saeidi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Beheshti Hospital, Beheshti Blvd, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Fax
Email
dr.msaeidi@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mohammad Saeidi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Beheshti Hospital, Beheshti Blvd, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Fax
Email
dr.msaeidi@hotmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available