Evaluation of the effect of N-acetylcysteine (NAC) on preventing creatinine increase in open heart surgery
Design
Clinical trial with control and intervention group, with parallel, non-randomized, phase 3 groups per 100 patients
Settings and conduct
The present study is a non-randomized and non-blinding clinical trial that was performed in Chamran Hospital in 1398. The statistical population of patients are candidates for CABG surgery. The effect of N-acetylcysteine (NAC) on the prevention of renal failure in open heart surgery will be investigated. The study population is all patients who have referred to the cardiac operating room of Isfahan Chamran Hospital for CABG surgery
Participants/Inclusion and exclusion criteria
Entry requirements
Age 40 to 65 years
Kidney filtering speed (GFR) greater than 60
Creatinine less than 1.5
Having conscious satisfaction
Patients who had no previous history of open heart surgery.
Patients undergoing heart surgery (CABG).
Patients who did not use extracellular membrane oxygenation (ECMO) and pump balloons before open heart surgery.
No entry conditions
Patients who are candidates for emergency CABG
Patients who had valve surgery in addition to CABG surgery
Patients undergoing CABG without a cardiopulmonary pump (CPB)
Intervention groups
The intervention group is given 1200 mg of NAC with Prime and the control group does not receive the drug
Main outcome variables
Kidney failure status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200823048491N1
Registration date:2020-12-20, 1399/09/30
Registration timing:retrospective
Last update:2020-12-20, 1399/09/30
Update count:0
Registration date
2020-12-20, 1399/09/30
Registrant information
Name
Leila Rostazadeh shekh yosefi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3532 0882
Email address
jebran.49@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-24, 1398/12/05
Expected recruitment end date
2020-12-19, 1399/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of N-acetylcysteine (NAC) in cardio-pulmonary pump device in preventing kidney failure in coronary heart surgery
Public title
The effect of N-acetylcysteine (NAC) on renal failure in Coronary surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 40 to 65 years
GFR greater than 60
Creatinine less than 1.5
Having conscious satisfaction
Patients with no previous history of open heart surgery
Patients undergoing CABG coronary artery bypass graft surgery
Patients who did not use ECMO and pump balloons before open heart surgery
Exclusion criteria:
Patients undergoing CABG without Cardiopulmonary pump (CPB)
Patients who had valve surgery in addition to CABG surgery
Patients who are candidates for emergency CABG
Age
From 40 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Isfahan University of Medical Sciences
Street address
Isfahan, Hezar Jerib St, Isfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Approval date
2020-02-24, 1398/12/05
Ethics committee reference number
IR.MUI.MED.REC.1398.663
Health conditions studied
1
Description of health condition studied
Patients undergoing open heart surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Evaluation of BUN
Timepoint
One and two days after surgery
Method of measurement
Through blood tests and sheets available in the ICU
2
Description
Creatinine
Timepoint
One and two days after surgery
Method of measurement
Through blood tests and sheets available in the ICU
3
Description
Urinary output
Timepoint
One and two days after surgery
Method of measurement
Through blood tests and sheets available in the ICU
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group for patients taking 1200 mg of NAC once in prime during cardiopulmonary pumping 1200 mg of NAC
Category
Treatment - Drugs
2
Description
Control group: For patients who are not taking NAC
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran Hospital
Full name of responsible person
Leila Roustazadeh Sheikh Yousefi
Street address
Shahid Chamran Hospital ،Mushtaq 3rd Street Isfahan town
City
Esfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3260 0961
Fax
+98 31 3260 0961
Email
dean@med.mui.ac.i
Web page address
http://med.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research and Technology
Street address
Isfahan Hezar Jerib St., Isfahan University of Medical Sciences and Health Services
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Fax
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Web page address
http://med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Leila Roustazadeh Sheikh Yousefi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isfahan, third Mushtaq street, Zayandehrud town
City
Esfahan
Province
Isfehan
Postal code
8158345932
Phone
+98 31 3532 0882
Email
LEILAEOSTA3131@GMAIL.COM
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Leila Roustazadeh Sheikh Yousefi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isfahan, third Mushtaq street, Zayandehrud town
City
Esfahan
Province
Isfehan
Postal code
8158345932
Phone
+98 31 3532 0882
Email
leilaeosta3131@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Leila Roustazadeh Sheikh Yousefi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isfahan - the third moshtagh
City
Esfahan
Province
Isfehan
Postal code
8158345932
Phone
+98 31 3532 0882
Email
leilarosta3131@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available