Effects of N-acetyl cysteine on the improvement of cardiopulmonary and renal functions after cardiopulmonary bypass in patients with coronary artery bypass graft
Effects of N-acetylcysteine on the improvement of cardiopulmonary and renal functions after cardiopulmonary bypass in patients with coronary artery bypass graft
Design
The clinical trial has a community-based, practice-oriented control group, with parallel groups, randomized
Settings and conduct
The effect of n-acetylcysteine during open heart surgery was performed in the heart surgery department at three different times.
Participants/Inclusion and exclusion criteria
Inclusion criteria were patients with age 25-75 years undergoing CPB for CABG. Exclusion criteria were patients for emergency CABG, redo CABG, and the intubation time after surgery for more than >10 hours and severe hemorrhage during CABG.
Intervention groups
In this study, an intervention group and a control group participated.In intervention group after induction, a central venous line was inserted and first blood sample (pre-CPB time) was obtained. After this stage, the intervention group received 100 mg/kg NAC into one liter normal saline and the control group received one liter normal saline one hour before initiating CPB.
Effects of N-acetyl cysteine on the improvement of cardiopulmonary and renal functions after cardiopulmonary bypass in patients with coronary artery bypass graft
Public title
Effects of N-acetyl cysteine on the improvement of cardiopulmonary and renal functions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria were patients with age 25-75 years undergoing cardio pulmonary bypass (CPB) for coronary artery bypass graft(CABG).
Exclusion criteria:
Exclusion criteria were patients for emergency coronary artery bypass graft(CABG)
Redo CABG
The intubation time after surgery for more than >10 hours
Severe hemorrhage during coronary artery bypass graft (CABG)
Age
From 25 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
49
Randomization (investigator's opinion)
Randomized
Randomization description
In this study patients who met inclusion criteria were divided into intervention and control group by simple randomization method.This method is one of basic methods for sampling in experimental studies, and frequently is used in studies with a few sample size.For randomization between two groups, random numbers table is used.In this study fifty patients with diagnosis of CABG in Heart surgery critical care unit of Ayatollah Mousavi hospital after matching for demographic data’s and Apache 2 Score we’re divided into intervention group and control group by randomization with computerized random number tables.Fifty random numbers were extracted of computer by using random number table and for example 24th sample was set in intervention group and 14th sample was set in control group and this process was performed until end of the study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Azadi Blvd, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2013-04-28, 1392/02/08
Ethics committee reference number
2/92-328-04
Health conditions studied
1
Description of health condition studied
Cardiac coronary arterial disease
ICD-10 code
I27.9
ICD-10 code description
I26-I28
Primary outcomes
1
Description
The ratio of partial pressure arterial oxygen and fraction of inspired oxygen(Pao2/Fio2)
Timepoint
The time points of blood sampling were after induction, before the administration of N-acetylcysteine (NAC) (pre-CPB)(Time 1) as baseline, one hour after CPB (on-CPB)(Time 2) , and one hour after that the patients were off-CPB (post-CPB)(Time 3).
Method of measurement
Pao2/Fio2 measurement kit was used to measure Pao2/Fio2 by atrial blood gas machine.
2
Description
Alveolar–arterial (A-a) gradient
Timepoint
The time points of blood sampling were after induction, before the administration of N-acetylcysteine (NAC) (pre-CPB)(Time 1) as baseline, one hour after CPB (on-CPB)(Time 2) , and one hour after that the patients were off-CPB (post-CPB)(Time 3).
Method of measurement
A-a gradient measurement kit was used to measure A-a gradient by atrial blood gas machine.
3
Description
Interleukin-6
Timepoint
The time points of blood sampling were after induction, before the administration of N-acetylcysteine (NAC) (pre-CPB)(Time 1) as baseline, one hour after CPB (on-CPB)(Time 2) , and one hour after that the patients were off-CPB (post-CPB)(Time 3).
Method of measurement
Interleukin-6 measurement kit was used to measure Interleukin-6.
4
Description
Shunt
Timepoint
The time points of blood sampling were after induction, before the administration of N-acetylcysteine (NAC) (pre-CPB)(Time 1) as baseline, one hour after CPB (on-CPB)(Time 2) , and one hour after that the patients were off-CPB (post-CPB)(Time 3).
Method of measurement
Using the formula used to measure it.
5
Description
Compliance reactive protein (CRP)
Timepoint
The time points of blood sampling were after induction, before the administration of N-acetylcysteine (NAC) (pre-CPB)(Time 1) as baseline, one hour after CPB (on-CPB)(Time 2) , and one hour after that the patients were off-CPB (post-CPB)(Time 3).
Method of measurement
Compliance reactive protein (CRP) measurement kit was used to measure Compliance reactive protein (CRP).
6
Description
CKMB
Timepoint
The time points of blood sampling were after induction, before the administration of N-acetylcysteine (NAC) (pre-CPB)(Time 1) as baseline, one hour after CPB (on-CPB)(Time 2) , and one hour after that the patients were off-CPB (post-CPB)(Time 3).
Method of measurement
Creatine kinase-muscle/brain (CKMB) measurement kit was used to measure creatine kinase-muscle/brain (CKMB).
7
Description
Troponine
Timepoint
The time points of blood sampling were after induction, before the administration of N-acetylcysteine (NAC) (pre-CPB)(Time 1) as baseline, one hour after CPB (on-CPB)(Time 2) , and one hour after that the patients were off-CPB (post-CPB)(Time 3).
Method of measurement
Troponine measurement kit was used to measure Troponine.
8
Description
Serum Lactate
Timepoint
The time points of blood sampling were after induction, before the administration of N-acetylcysteine (NAC) (pre-CPB)(Time 1) as baseline, one hour after CPB (on-CPB)(Time 2) , and one hour after that the patients were off-CPB (post-CPB)(Time 3).
Method of measurement
Lactate measurement kit was used to measure Lactate.
9
Description
Creatinine
Timepoint
The time points of blood sampling were after induction, before the administration of N-acetylcysteine (NAC) (pre-CPB)(Time 1) as baseline, one hour after CPB (on-CPB)(Time 2) , and one hour after that the patients were off-CPB (post-CPB)(Time 3).
Method of measurement
Creatinine measurement kit was used to measure Creatinine.
10
Description
Ejection fraction
Timepoint
The time points of blood sampling were after induction, before the administration of N-acetylcysteine (NAC) (pre-CPB)(Time 1) as baseline, and one hour after that the patients were off-CPB (post-CPB)(Time 3).
Method of measurement
Using the formula used to measure it.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After induction, a central venous line was inserted and first blood sample (pre-CPB time) was obtained. After this stage, the NAC group received 100 mg/kg NAC.
Category
Treatment - Drugs
2
Description
Control group: the control group received normal saline one hour before initiating CPB.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi hospital
Full name of responsible person
Mohammadreza Jamshidi
Street address
Ayatollah Mousavi Hospital, Sobotie Blvd, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Fax
+98 24 3313 1419
Email
jamshidianes@zums.ac.ir
Web page address
http://www.zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Alireza shoghli
Street address
Azadi Blvd, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3322 4766
Fax
+98 24 3322 4766
Email
research@zums.ac.ir
Web page address
http://zums.ac.ir/index.php?slc_lang=fa&sid=3
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
50
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mohammadreza Jamshidi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Mousavy Hospital, Sobotie Blvd, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Fax
+98 24 3313 1203
Email
jamshidianes@zums.ac.ir
Web page address
http://www.zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mohammadreza Jamshidi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Zanjan,Gavazang Ave ,Mousavy Hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Fax
+98 24 3313 1203
Email
jamshidianes@zums.ac.ir
Web page address
http://www.zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
azarakhsh Barbod
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ayatollah Mousavy Hospital, Sobotie Blvd, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Fax
+98 24 3313 1203
Email
azarakhsh.barbod@yahoo.com
Web page address
http://www.zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
After completing the study, there is a plan to share non-identifiable individual data of the participants, the study protocol, the statistical analysis of the data, the informed consent form patents, clinical reports, analysis codes, and data coding systems (Dictionary).
When the data will become available and for how long
The start of the access period to the data of this study will be from mid-2019 and approximately 6 months after the publication of the results
To whom data/document is available
The data from this study will be available to all people who can play a role in caring for CABG patients, such as families, and healthcare workers.
Under which criteria data/document could be used
The researcher tend to use data to improve patients, especially CABG patients.
From where data/document is obtainable
To receive information anyone can be use the following email: jamshidianes@zums.ac.ir
What processes are involved for a request to access data/document
The data will be sent to the applicants after her introduction and the reason for the need for data.