The effect of N-acetyl cysteine on the prevention of hepatic ischemia after open heart surgery
Design
In this study, 60 patients with blind double-sided blind clinical trial were randomly divided into two groups of intervention and control.
Settings and conduct
In this study, 60 patients who are candidates for open heart surgery in Golestan Hospital of Ahvaz will be selected as available and will be divided into two groups of intervention and control in a simple random manner. They will receive mg/kg of N-acetyl cysteine. In the control group, after induction of anesthesia and intubation, 150 mg / kg normal saline will be given intravenously. In order to conduct a two-way blind study of patients and researchers who inject the drug and take a blood sample from They don't know which medicine or which drug.
Participants/Inclusion and exclusion criteria
Criteria for admission: Open heart surgery; age 30 to 70 years; normal kidney and liver function; no diabetes, hypertension, thyroid dysfunction and cardiac arrhythmia; no addiction
Intervention groups
In the intervention group, after induction of anesthesia and intubation, 150 mg / kg N-acetylcysteine will be administered intravenously.
In the control group, after induction of anesthesia and intubation, 150 mg / kg normal saline will be administered intravenously.
Main outcome variables
Patients who entered the study would be screened for serum Alkaline Phosphatase, Aspartate Aminotransferase, alanine, Aalanine Aminotransferase, Gamma Glutamyl Transferase, and Bilirubin in a blood test after open heart surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190506043492N2
Registration date:2020-05-23, 1399/03/03
Registration timing:retrospective
Last update:2020-05-23, 1399/03/03
Update count:0
Registration date
2020-05-23, 1399/03/03
Registrant information
Name
Milad Arabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3001
Email address
arabi.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2020-01-05, 1398/10/15
Actual recruitment start date
2018-09-11, 1397/06/20
Actual recruitment end date
2020-01-10, 1398/10/20
Trial completion date
2020-01-10, 1398/10/20
Scientific title
Investigation of the effect of N-acetyl cysteine on liver function after open heart surgery
Public title
the effect of N-acetyl cysteine on liver function after open heart surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Entry Criteria: Candidates for open heart surgery
Be 30 to 70 years old
Have normal kidney and liver function
Do not have thyroid disease, hypertension, diabetes and arrhythmia
Don't be addicted to drugs.
Exclusion criteria:
Output criterion: The patient is not satisfied to participate in the study
If the patient is taking effective drugs such as steroids, anti-inflammatory or anti fungal drugs
If you are allergic to N-acetyl cysteine
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly selected and divided into two groups of interventions (recipient of N-acetyl cysteine) and control (normal recipient of saline) through a table of random numbers assigned to even numbers for the intervention group and individual numbers for the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients were unaware that they were in the receiving group of N-acetyl cysteine or normal saline, The person injecting the drug did not know if the syringe contained N-acetyl cysteine or normal saline, Because the drug was taken by another anesthesiologist and labeled 1 and 2, and Finally, the person who took the blood sample from the patients for liver tests did not know the type of intervention and the type of medicine that had been injected for the patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of ahvaz jundishapur University of Medical Sciences
Street address
Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, Golestan BLvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357157941
Approval date
2019-08-19, 1398/05/28
Ethics committee reference number
IR.AJUMS.REC.1398.391
Health conditions studied
1
Description of health condition studied
Liver diseas
ICD-10 code
K76.9
ICD-10 code description
Liver disease, unspecified
Primary outcomes
1
Description
The effect of N-acetyl cysteine on liver enzymes after open heart surgery
Timepoint
Before anesthesia, 1, 24 and 48 hours later
Method of measurement
Serum levels of alkaline phosphatase in blood tests
2
Description
The effect of N-acetyl cysteine on liver enzymes after open heart surgery
Timepoint
Before anesthesia, 1, 24 and 48 hours later
Method of measurement
Serum levels of Aspartate Aminotransferase Alanine in blood tests
3
Description
The effect of N-acetyl cysteine on liver enzymes after open heart surgery
Timepoint
Before anesthesia, 1, 24 and 48 hours later
Method of measurement
Serum levels of Aminotransferase in blood tests
4
Description
The effect of N-acetyl cysteine on liver enzymes after open heart surgery
Timepoint
Before anesthesia, 1, 24 and 48 hours later
Method of measurement
Serum levels of Gamma Glutamyl Transferase in blood tests
5
Description
The effect of N-acetyl cysteine on liver enzymes after open heart surgery
Timepoint
Before anesthesia, 1, 24 and 48 hours later
Method of measurement
Serum levels of Bilirubin in blood tests
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After induction of anesthesia and intubation, they will receive 150 mg / kg n-acetylcysteine intravenously (Oxy-Nak, Elixir Pharmacy, Boroujerd, Iran).
Category
Prevention
2
Description
Control group: After induction of anesthesia and intubation, intravenous administration of 150 mg / kg normal saline will be given.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Pegah Abbasi Hormozi
Street address
Golestan Hospital, Golestan Boulevard
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
Shima.abbacihormozi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Vice Chancellor For Research of Ahvaz Jundishapour University of Medical Sciences, Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
Shimaabbacihormozi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Pegah Abbasi Hirmozi
Position
Associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan BLvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
Shima.abbacihormozi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Pegah Abbasi Hormozi
Position
Associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
Shima.abbacihormozi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Pegah Abbasi Hormozi
Position
Associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan BLvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
Shima.abbacihormozi@yaoo.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
Undecided - It is not yet known if there will be 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
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available