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The effect of adding the N-acetylcysteine drug to Del Nido's cardioplegia solution on the oxidative stress capacity In patients undergoing coronary artery bypass surgery

Protocol summary

Study aim
In case of proving the protective, preserving and increasing antioxidant effect and countering the negative effects of N-acetylcysteine ​​free radicals, a more appropriate strategy can be adopted to reduce the complications of ischemia and reperfusion.
Design
Patients are divided into two groups of 30 based on randomized block size 4. A list of how patients are crashed into a closed envelope is provided to the researcher and patients are assigned to each of the intervention and control groups before the aortic clamp is opened, performed by the researcher.
Settings and conduct
This research is a randomized, controlled, single-blind clinical trial to investigate the protective effect of adding N-acetylcysteine ​​to Del Nido's cardioplegia solution in patients undergoing elective open heart surgery, including coronary artery procedures, in Shahid Rajaei's operating room.
Participants/Inclusion and exclusion criteria
No history of heart surgery, Left ventricular ejection fraction greater than 30% Hemoglobin above 10 milligram per deciliter No kidney or liver dysfunction Lack of impaired lung function tests
Intervention groups
In the intervention group, the amount of 50 mg/kg N-acetylcysteine ​​will be injected in Del Nido's cardioplegia solution. The control group will only receive Del Nido Rutin cardioplegia solution. During surgery, moderate hypothermia (32-34°C) will be induced and mean arterial pressure will be maintained at 50-80 mm Hg.
Main outcome variables
Determining and comparing the mean ejection fraction Determining and comparing the mean level of cardiac enzymes (troponin, creatine kinase-MB, lactate dehydrogenase) Determining and comparing the mean level of malonyldialdehyde as the main biomarker of oxidative stress, glutathione peroxidase enzyme level before and after open Aortic clamping

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231021059790N1
Registration date: 2024-08-01, 1403/05/11
Registration timing: prospective

Last update: 2024-08-01, 1403/05/11
Update count: 0
Registration date
2024-08-01, 1403/05/11
Registrant information
Name
Khadijeh Nazari
Name of organization / entity
Shaheed Rajaie Cardiovascular, Medical & Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 23921
Email address
kh.nazari@rhc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-05, 1403/05/15
Expected recruitment end date
2024-12-20, 1403/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding the N-acetylcysteine drug to Del Nido's cardioplegia solution on the oxidative stress capacity In patients undergoing coronary artery bypass surgery
Public title
The effect of adding the N-acetylcysteine drug to Del Nido's cardioplegia solution on the oxidative stress capacity In patients undergoing coronary artery bypass surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient consent to study study Age over 39 years and under 70 years No history of sternotomy and heart surgery Left ventricular ejection fraction greater than 30% Pulmonary outflow volume with pressure per second (FEV1) greater than 65% in spirometry Hemoglobin above 10 mg per deciliter
Exclusion criteria:
Need for drug support (receiving inotropes before starting heart surgery) Having a pacemaker Having impaired lung function tests for FEV1 less than 40% Having kidney or liver dysfunction Pump time more than 120 minutes Cross clamp less than 45 and more than 100 minutes Allergy to N-acetylcysteine
Age
From 39 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Care provider
Sample size
Target sample size: 60
More than 1 sample in each individual
Number of samples in each individual: 4
5 minutes before the aortic clamp and 5 minutes after the aortic clamp is opened
Randomization (investigator's opinion)
Randomized
Randomization description
Based on randomization, the patients are divided into 2 groups of 30 people in random blocks of size 4. The list of how to randomize the patients in the sealed envelope is at the discretion of the researcher, and the allocation of patients to each of the intervention and control groups is done by the researcher before opening the aortic clamp.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the intensive care unit nurse who is responsible for caring for the patient is kept blind.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Rajaie cardiovascular, medical and research center
Street address
2nd Floor, operating room, corner of Niayesh, next to Mellat Park, Vali Asr St. (AS)
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2024-06-15, 1403/03/26
Ethics committee reference number
IR.RHC.REC.1403.037

Health conditions studied

1

Description of health condition studied
The protective and antioxidant effect of adding N-acetylcysteine ​​to del nido's cardioplegia solution in coronary artery surgeries
ICD-10 code
I21.A1
ICD-10 code description
subsequent myocardial infarction, type 2

Primary outcomes

1

Description
Type of heart rhythm
Timepoint
After removal of the aortic clamp
Method of measurement
ECG curve shape and heart rate per minute

2

Description
Return time of sinus rhythm of the heart
Timepoint
After removal of the aortic clamp
Method of measurement
Minutes

3

Description
Need for antiarrhythmic drugs
Timepoint
After removal of the aortic clamp
Method of measurement
Yes or no

4

Description
Consumption of inotropic after opening the aortic clamp
Timepoint
After removal of the aortic clamp
Method of measurement
Micrograms per kilogram per hour

5

Description
Requires defibrillator
Timepoint
After removal of the aortic clamp
Method of measurement
Yes or no

6

Description
Need a pacemaker
Timepoint
After removal of the aortic clamp
Method of measurement
Yes or no

7

Description
The amount of lactate
Timepoint
After separation of cardiopulmonary bypass machine
Method of measurement
Mg per liter

8

Description
Cardiac enzymes (troponin, Lactate Dehydrogenase and Creatine kinase-MB levels)
Timepoint
Before surgery, 12 and 24 hours after surgery
Method of measurement
Micrograms per deciliter

9

Description
Heart ejection fraction
Timepoint
Before and after surgery
Method of measurement
Echo of the heart and in percent

10

Description
Glutathione peroxidase and Malonyl di aldehyde
Timepoint
Before the aortic clamp and 5 minutes after the opening of the aortic clamp from the coronary sinus
Method of measurement
coronary sinus blood samples in units per liter

11

Description
Duration of mechanical ventilation
Timepoint
Duration of the patient's arrivalafter surgery to the intensive care unit
Method of measurement
Hour

Secondary outcomes

1

Description
Blood pressure
Timepoint
During the injection of cardioplegic solution
Method of measurement
Mm of mercury

Intervention groups

1

Description
Intervention group: After fully connecting the patient to the cardiopulmonary pump, Del Nido's cardioplegia solution, which is electrolytically similar to the extracellular fluid and whose temperature is between 2 and 8 degrees Celsius, is injected into the patient's aortic root in an antegrade manner after the aortic clamp. will be. In the intervention group, 50 mg/kg N-acetylcysteine ​​will be injected in the same solution.
Category
Prevention

2

Description
Control group: After fully connecting the patient to the cardiopulmonary pump, Del Nido's cardioplegia solution, which is electrolytically similar to the extracellular fluid and whose temperature is between 2 and 8 degrees Celsius, is injected into the patient's aortic root in an antegrade manner after the aortic clamp. will be. The control group will only receive Del Nido Rutin cardioplegia solution.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Rajaei Cardiovascular Hospital
Full name of responsible person
Dr. Farshad Jalili Shahandashti
Street address
Next to Mellat Park, Vali Asr Ave, Tehran, IRAN.
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
kh.nazari9372@gmail.com
Web page address
http://rhc.ac.ir/fa

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Rajaei Cardiovascular Hospital
Full name of responsible person
Dr. Farshad Jalili Shahandashti
Street address
2nd Floor, operating room, corner of Niayesh, next to Mellat Park, Vali Asr St. (AS)
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
kh.nazari9372@gmail.com
Web page address
http://rhc.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Rajaei Cardiovascular Hospital
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Rajaei Cardiovascular Hospital
Full name of responsible person
Khadijeh Nazari
Position
Master student of perfusion
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
2nd Floor, operating room, corner of Niayesh, next to Mellat Park, Vali Asr St. (AS)
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
kh.nazari9372@gmail.com
Web page address
http://rhc.ac.ir/fa

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Rajaei Cardiovascular Hospital
Full name of responsible person
Dr. Farshad Jalili Shahandashti
Position
Associate professor of heart surgery
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
2nd Floor, operating room, corner of Niayesh, next to Mellat Park, Vali Asr St. (AS)
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
Jalilishfarshad@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Rajaei Cardiovascular Hospital
Full name of responsible person
Khadijeh Nazari
Position
Master student of perfusion
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Next to Mellat Park, Vali Asr Ave, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
kh.nazari9372@gmail.com
Web page address
http://rhc.ac.ir/fa

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
Based on the consent obtained from patients, their information remains confidential.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
In this study, the names and surnames of the individuals remain confidential, but the results of the study and their consequences are shared.
When the data will become available and for how long
Approximately 6 months from the time of sampling
To whom data/document is available
Data only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
After completing the work and publishing the dissertation at the university. Those who want to have access please refer to the center library.
From where data/document is obtainable
After completing the work and publishing the dissertation at the university. Those who want to have access please refer to the center library.
What processes are involved for a request to access data/document
After completing the work and publishing the dissertation at the university, Those who want to have access please refer to the center library.
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