Effect of N-acetyl Cysteine (NAC) on contrast-induced nephropathy in patients with basal urinary neutrophil gelatinase-associated lipocalin (NGAL) positive underwent angiography or coronary intervention (PCI): A single blind randomized clinical trial
Effect of N-acetyl Cysteine on contrast-induced nephropathy in patients with basal urinary neutrophil gelatinase-associated lipocalin positive underwent angiography or coronary intervention
Design
Clinical trial, Phase 3, Have control group,with parallel groups, single blind, Sample size 110, Permuted block randomization
Settings and conduct
This study will be carried out using clinical trial in Farshchian Cardiovascular Hospital, Hamadan
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 to 90 years, Under angiography or coronary artery intervention
Exclusion criteria: Kidney disease, Urinary tract infection, Urinary tract tumor, Use of Nephrotoxic or Antibiotic drugs or contrast media within past week
Intervention groups
Intervention group: intravenous hydration 2 to 3 cc per kilogram and N-acetylcysteine oral 1200 mg twice daily for 3 days.
control group: intravenous hydration 2 to 3 cc per kilogram
Main outcome variables
Creatinine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190311043011N1
Registration date:2019-03-17, 1397/12/26
Registration timing:registered_while_recruiting
Last update:2019-03-17, 1397/12/26
Update count:0
Registration date
2019-03-17, 1397/12/26
Registrant information
Name
Azadeh Mozayani Monfared
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1731
Email address
azadeh_m27@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-11, 1397/12/20
Expected recruitment end date
2019-09-11, 1398/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of N-acetyl Cysteine (NAC) on contrast-induced nephropathy in patients with basal urinary neutrophil gelatinase-associated lipocalin (NGAL) positive underwent angiography or coronary intervention (PCI): A single blind randomized clinical trial
Public title
Effect of N-acetyl Cysteine (NAC) on contrast-induced nephropathy in patients with basal urinary neutrophil gelatinase-associated lipocalin (NGAL) positive underwent angiography or coronary intervention (PCI): A single blind randomized clinical trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 90 years
Undergoing angiography or coronary artery intervention
Exclusion criteria:
Kidney disease
Urinary tract infection
Urinary tract tumor
Use of Nephrotoxic or Antibiotic drugs or contrast media within past week
Age
From 18 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
110
More than 1 sample in each individual
Number of samples in each individual:
3
one urine sample, two blood sample
Randomization (investigator's opinion)
Randomized
Randomization description
For this purpose, we will use four random blocks method. For this purpose, we will prepare four paper sheets. On the two sheets of the letter "I" means "Intervention" and on the other two letters "C" meaning "Control". we will mix the sheets and place them in the drawer. For each eligible patient, one of the sheets will be drawn randomly and based on the letter I or C, patient will be assigned to one of the two groups. It should be noted that the drawn sheets will not be returned to the drawer until all four sheets will been drawn out. After all four sheets will be drawn, all will be returned to the drawer and above process will continue until the sample size will be reached.
Blinding (investigator's opinion)
Single blinded
Blinding description
The laboratory will be unaware of the patient receiving or not receiving the drug, so the study will be done single blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, SHahid Fahmideh Blvd
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2019-03-10, 1397/12/19
Ethics committee reference number
IR.UMSHA.REC.1397.964
Health conditions studied
1
Description of health condition studied
Contrast- Induced Nephropathy disease
ICD-10 code
N17.8
ICD-10 code description
Other acute kidney failure
Primary outcomes
1
Description
Serum creatinine
Timepoint
Before and 48 hours after the intervention
Method of measurement
blood test
2
Description
Neutrophil Gelatinase Associated Lipocalin
Timepoint
Before the intervention
Method of measurement
Urine Test
Secondary outcomes
empty
Intervention groups
1
Description
Oral acetylcysteine (NAC) tablet of 1200 mg twice daily for 3 days
Category
Prevention
2
Description
Control group: Venous hydration 2-3cc / kg
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian heart hospital
Full name of responsible person
Azadeh Mozayani Monfared
Street address
Shahid Fahmideh Blvd, Farshchian heart hospital
City
Hamadan
Province
Hamadan
Postal code
6517839131
Phone
+98 81 3838 1720
Email
azadeh_m27@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Azadeh Mozayani Monfared
Street address
Shahid Fahmideh Blvd, Hamadan Univesity of Medical Science
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 1720
Email
azadeh_m27@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Azadeh Mozayani Monfared
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Shahid Fahmideh Blvd, Farshchian heart hospital
City
Hamadan
Province
Hamadan
Postal code
6517839131
Phone
+98 81 3838 1720
Email
azadeh_m27@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Azadeh Mozayani Monfared
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Shahid Fahmideh Blvd, Farshchian heart hospital
City
Hamadan
Province
Hamadan
Postal code
6517839131
Phone
+98 81 3838 1720
Email
azadeh_m27@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Azadeh Mozayani Monfared
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
SHahid Fahmideh Blvd, Farshchian Heart Hospital
City
Hamadan
Province
Hamadan
Postal code
6517839131
Phone
+98 81 3838 1720
Email
azadeh_m27@yahoo.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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
We are not collecting data
When the data will become available and for how long
one year
To whom data/document is available
No decision has been made yet
Under which criteria data/document could be used
No decision has been made yet
From where data/document is obtainable
Research Center of farshchian heart center
What processes are involved for a request to access data/document
Presentations letter from the University Research Center