Investigation of changes in lactate levels and inflammatory factors in patients undergoing CABG surgery due to selenium injection
Design
The present clinical trial had a control group and an intervention in which the study population was randomly and individually based on random admission code. The project will be implemented in phase 0 clinical on 80 patients.
Settings and conduct
The clinical trial is being held at Masih Daneshvari Hospital in Tehran. Patients in the selenium group received 500 mg of selenium intravenously before surgery and at the same time at the end of surgery, while in the placebo group they received the same amount of normal saline. Patients are then anesthetized in the same way and placed on a heart pump. The variables are then measured during and after the operation in the ICU.
Participants/Inclusion and exclusion criteria
Entry requirements:
- 18 <Age <65
- EF = 40-55%
Conditions of non-entry:
• Emergency surgery
• Simultaneous valve and coronary surgery
• Age over 75 years
• History of kidney and liver disease (enzymes 2 times normal)
• Drug sensitivity
• Recent MI (in 7 days)
• IABP before surgery
• BMI <12
Intervention groups
In total, 80 patients underwent CABG surgery in two control groups (40 patients) and intervention (40 patients) in this clinical trial.
Main outcome variables
Patient serum lactate levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150725023332N2
Registration date:2020-06-24, 1399/04/04
Registration timing:registered_while_recruiting
Last update:2020-06-24, 1399/04/04
Update count:0
Registration date
2020-06-24, 1399/04/04
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2283 1058
Email address
alirezajahangiri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of injectable selenium administration on serum lactate level in patients undergoing CABG
Public title
The effect of selenium consumption in patients undergoing CABG surgery
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing CABG surgery
18 <Age <65
EF=40-55%
Exclusion criteria:
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this randomized trial, Sai was performed in a simple and individual manner with emphasis on patient admission code.
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 Shahid Beheshti University of Medical Sciences