Protection rule of N-acetyl L-cysteine in improvement of pulmonary condition in chronic obstructive pulmonary disease (COPD) patients after coronary artery bypass grafting (CABG) surgery
In previous studies, during acute attack of COPD level of oxidants increases in human body and natural anti-oxidants are not able to neutralization them.Inclusion criteria:Age 25 to 60 years old;Ejection fraction more than or equal to 40 percent
Exclusion criteria :Massive blood transfusion; Any complication caused prolongation of operation or intubation. During open heart surgery, pulmonary-heart pump decreases anti-oxidants level and increases oxidants. The COPD patients who are undergoing to open heart surgery, after surgery more pulmonary complications occur than the patients without pulmonary problem. N-acetyl cysteine (NAC) is an antioxidant that in this study as prevention effects of heart-pulmonary pump are studied.ُSixty patients were randomly divided in random fix block method into two groups of 1 and 2 . The first group received 9 doses of NAC 200mg NAC during operation and second group received placebo (Normal saline) at the same time and in the same dose. Patients will be followed for 30 days after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201509064345N5
Registration date:2015-10-04, 1394/07/12
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-10-04, 1394/07/12
Registrant information
Name
Ali Mirmansouri
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1666 9064
Email address
a_mirmansoori@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan university of medical sciences
Expected recruitment start date
2015-10-07, 1394/07/15
Expected recruitment end date
2016-03-05, 1394/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Protection rule of N-acetyl L-cysteine in improvement of pulmonary condition in chronic obstructive pulmonary disease (COPD) patients after coronary artery bypass grafting (CABG) surgery
Public title
The effect of N-acetyl L-cysteine in Chronic obstructive pulmonary disease
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Age 25 to 60 years old;Ejection fraction more than or equal to 40 percent
Exclusion criteria :Massive blood transfusion; Any complication caused prolongation of operation or intubation
Age
From 25 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Guilan University of Medical Sciences
Street address
Shahid Beheshti Freeway
City
Rasht
Postal code
4193893345
Approval date
2015-08-24, 1394/06/02
Ethics committee reference number
IR.GUMS.REC.1394.201
Health conditions studied
1
Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease
Primary outcomes
1
Description
PULMONARY FUNCTION
Timepoint
Before surgery,5,15,30 days after surgery
Method of measurement
PULMONARY FUNCTION TEST(PFT)/With spirometery/Bionet SPM 300/ south Korea
2
Description
Arterial blood gas (ABG)
Timepoint
Before and after surgery then every 4 hours in ICU
Method of measurement
blood from an artery intraarterial cannula/convergent
Secondary outcomes
empty
Intervention groups
1
Description
Intervention1: In group N-acetylcysteine, before surgery, injected the first dose of 200 mg per mL of N-acetyl L-cysteine / EXIR Co./IRAN
Category
Treatment - Drugs
2
Description
placebo group: Similar to intervention 1 classification, but we used placebo (NS intravenously instead of NAC)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Heshmat Hospital
Full name of responsible person
Ali Mirmansouri
Street address
Fifteenth Khordad
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidarzadeh
Street address
Shahid Beheshti Freeway
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Ali Mirmansouri
Position
Anesthesiologist
Other areas of specialty/work
Street address
Heshmat Hospital
City
Rasht
Postal code
4193713194
Phone
+33 368534
Fax
+98 13 3336 8651
Email
mirmansoori_ali@yahoo.comarcguilan1392@gmail.com
Web page address
www.arc.gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Science
Full name of responsible person
Ali Mirmansouri
Position
Anesthesiologist
Other areas of specialty/work
Street address
Dr.Heshmat Hospital
City
Rasht
Postal code
4193833697
Phone
+33 368534
Fax
+98 13 3336 8651
Email
mirmansoori_ali@yahoo.comarcguilan1392@gmail.com
Web page address
www.arc.gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Hedyeh Nemati
Position
Medical laboratory Sciences Technician/ Bachelor's Degree
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4193713194
Phone
+33 368534
Fax
+98 13 3336 8651
Email
arcguilan392@gmail.com
Web page address
www.arc.gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)