Prophylactic effect of N-acetyl-cysteine plus Atorvastatin versus N-acetyl-cysteine and Atorvastatin alone for the prevention of contrast induced nephropathy in patients undergoing elective angiography with or without percutaneous coronary intervention: a single center prospective randomized controlled trial
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Protocol summary
The primary outcome was CIN and the secondary clinical end points were hemodialysis and mortality within 48 hours after contrast media exposure .
The primary outcome was serum creatinine alteration and the secondary clinical end point was incidence of CIN within 48 hours after contrast media exposure .
The primary outcome was CINserum creatinine alteration and the secondary clinical end points were hemodialysis and mortalitypoint was incidence of CIN within 48 hours after contrast media exposure .
نتیجه اولیه نفروپاتی ناشی ازماده حاجب ,نتایج ثانویه شامل همودیالیز و مرگ ومیر می باشد
نتیجه اولیه تغییرات سطح کراتینین ,نتیجه ثانویه نفروپاتی ناشی ازماده حاجب می باشد
نتیجه اولیه تغییرات سطح کراتینین ,نتیجه ثانویه نفروپاتی ناشی ازماده حاجب ,نتایج ثانویه شامل همودیالیز و مرگ ومیر می باشد
General information
2018-11-22, 1397/09/01
2020-08-22, 1399/06/01
20182020-1108-22 00:00:00
2018-12-21, 1397/09/30
2020-11-21, 1399/09/01
20182020-1211-21 00:00:00
The inclusion criteria were mistakenly written for people with normal kidney function, which has now been corrected
Insufficient sample size of individuals with abnormal kidney function in this study and the start of new sampling of individuals with abnormal kidney function
The inclusion criteria were mistakenly written for peopleInsufficient sample size of individuals with normalabnormal kidney function, which has now been corrected in this study and the start of new sampling of individuals with abnormal kidney function
در مورد شرایط ورود به مطالعه به اشتباه افراد با عملکرد طبیعی کلیه نوشته شده بود که هم اکنون اصلاح گردید
ناکافی بودن حجم نمونه افراد با عملکرد غیر طبیعی کلیه در این پژوهش و شروع نمونه گیری جدید افراد با عملکرد کلیه غیر طبیعی
در مورد شرایط ورود به مطالعه به اشتباهناکافی بودن حجم نمونه افراد با عملکرد غیر طبیعی کلیه نوشته شده بود که هم اکنون اصلاح گردیددر این پژوهش و شروع نمونه گیری جدید افراد با عملکرد کلیه غیر طبیعی
Primary outcomes
#1
Serum creatinine level
Serum creatinine level altration
Serum creatinine level altration
سطح سرمی کراتینین
تغییرات سطح سرمی کراتینین
تغییرات سطح سرمی کراتینین
Secondary outcomes
#1
Need for hemodialysis
incidence of CIN
Need for hemodialysisincidence of CIN
همودیالیز
بروز نفروپاتی
همودیالیزبروز نفروپاتی
#2
Mortality
empty
Mortality
مرگ و میر
empty
مرگ و میر
48 h post exposure contrast media
empty
48 h post exposure contrast media
48 پس از دریافت ماده حاجب
empty
48 پس از دریافت ماده حاجب
Medical record
empty
Medical record
پرونده پزشکی
empty
پرونده پزشکی
Intervention groups
#1
گروه مداخله: گروه دوم قبل و بعد از پروسیجر کرونری80 میلی گرم اتوروستاتین دریافت می کنند (Atorvastatin 80 mg group)
گروه مداخله: گروه دوم قبل از پروسیجر کرونری80 میلی گرم اتوروستاتین دریافت می کنند (Atorvastatin 80 mg group)
گروه مداخله: گروه دوم قبل و بعد از پروسیجر کرونری80 میلی گرم اتوروستاتین دریافت می کنند (Atorvastatin 80 mg group)
#2
Intervention group: Group IV was prescribed 80 mg of Atorvastatin before and after the coronary procedure plus N-acetylcysteine as a sum of 1200 mg before and 600 mg after the coronary procedure (Atorvastatin 80 mg plus NAC 1800 mg).
Intervention group: Group IV was prescribed 80 mg of Atorvastatin before the coronary procedure plus N-acetylcysteine as a sum of 1200 mg before and 600 mg after the coronary procedure (Atorvastatin 80 mg plus NAC 1800 mg).
Intervention group: Group IV was prescribed 80 mg of Atorvastatin before and after the coronary procedure plus N-acetylcysteine as a sum of 1200 mg before and 600 mg after the coronary procedure (Atorvastatin 80 mg plus NAC 1800 mg).
گروه مداخله: گروه چهارم قبل و بعد از پروسیجر کرونری80 میلی گرم اتوروستاتین و ان استیل سیستئین با دوز 600 میلی گرم خوراکی به صورت بولوس 12 ساعت قبل از پروسیجر و اندکی قبل از پروسیجر و اندکی بعد از پروسیجر کرونری مجموعا 1200 میلی گرم قبل از پروسیجر و600 میلی گرم بعد از پروسیجر دریافت می کنند (NAC 1800 mg plus Atorvastatin 80 mg group )
گروه مداخله: گروه چهارم قبل از پروسیجر کرونری80 میلی گرم اتوروستاتین و ان استیل سیستئین با دوز 600 میلی گرم خوراکی به صورت بولوس 12 ساعت قبل از پروسیجر و اندکی قبل از پروسیجر و اندکی بعد از پروسیجر کرونری مجموعا 1200 میلی گرم قبل از پروسیجر و600 میلی گرم بعد از پروسیجر دریافت می کنند (NAC 1800 mg plus Atorvastatin 80 mg group )
گروه مداخله: گروه چهارم قبل و بعد از پروسیجر کرونری80 میلی گرم اتوروستاتین و ان استیل سیستئین با دوز 600 میلی گرم خوراکی به صورت بولوس 12 ساعت قبل از پروسیجر و اندکی قبل از پروسیجر و اندکی بعد از پروسیجر کرونری مجموعا 1200 میلی گرم قبل از پروسیجر و600 میلی گرم بعد از پروسیجر دریافت می کنند (NAC 1800 mg plus Atorvastatin 80 mg group )
Protocol summary
Study aim
Prophylactic role of NAC and Atorvastatin in preventing contrast induced nephropathy in patients undergoing angiography with or without PCI
Design
This single blind randomized controlled trial will be performed as a community-based and pragmatic control group with parallel groups.
Settings and conduct
This investigation included 250 participants admitting for elective coronary angiography with or without percutaneous coronary intervention in Ali-ebn Abitaleb Hospital, Shiraz, Iran. After being qualified for study entrance, the patients were obtained an informed consent and were randomly categorized in 4 groups. This study is also single blind, so patients do not notified whether they were in intervention or control group.
Participants/Inclusion and exclusion criteria
Eligible patients consist of individuals older than 21 years old with abnormal renal function (creatinine clearance between 15 and 60 mL/min or serum creatinine (SCr) ≥1.1 mg/dL) undergoing elective cardiac catheterization with or without PCI.
Exclusion criteria: patients with end-stage renal failure (glomerular filtration rate (GFR) ≤ 15 mL/min); history of previous dialysis; pulmonary edema; emergency cardiac catheterization (patients with ST-segment elevation myocardial infarction undergoing primary PCI ); exposure to contrast within previous two days ago before procedure; allergies to contrast media; liver disease and contraindication to statins.
Intervention groups
These individuals were randomly categorized in 4 groups with the following features: Group I (considered as control), Group II (statin 80 mg), Group III (NAC 1800 mg) and Group IV (statin 80 mg plus NAC 1800 mg)
Main outcome variables
The primary outcome was serum creatinine alteration and the secondary clinical end point was incidence of CIN within 48 hours after contrast media exposure .
General information
Reason for update
Insufficient sample size of individuals with abnormal kidney function in this study and the start of new sampling of individuals with abnormal kidney function
Acronym
IRCT registration information
IRCT registration number:IRCT20180417039347N1
Registration date:2018-11-20, 1397/08/29
Registration timing:prospective
Last update:2020-08-09, 1399/05/19
Update count:2
Registration date
2018-11-20, 1397/08/29
Registrant information
Name
Saeed KESHTKAR
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3225 8032
Email address
s.keshtkar20@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prophylactic effect of N-acetyl-cysteine plus Atorvastatin versus N-acetyl-cysteine and Atorvastatin alone for the prevention of contrast induced nephropathy in patients undergoing elective angiography with or without percutaneous coronary intervention: a single center prospective randomized controlled trial
Public title
Prophylactic effect of N-acetyl-cysteine plus Atorvastatin versus N-acetyl-cysteine and Atorvastatin alone for the prevention of contrast induced nephropathy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Eligible patients include individuals older than 21 years old
abnormal renal function (Creatinine clearance between 15 and 60 mL/min or serum creatinine (SCr) ≥1.1 mg/dL)
Undergoing elective cardiac catheterization with or without PCI
Exclusion criteria:
Patients with end-stage renal failure (glomerular filtration rate (GFR) ≤ 15 mL/min),
history of previous dialysis
pulmonary edema
emergency cardiac catheterization (patients with ST-segment elevation myocardial infarction undergoing primary PCI ),
exposure to contrast within previous two days ago before procedure
allergies to contrast media,
contraindication to statins
liver disease
Age
From 21 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
250
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random allocation method using variable blocks was used by statistical software for experimental and control groups
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, patients have been blinded about the intervention protocols .
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of zahedan university of medical science
Street address
Zahedan University of Medical Science, Dr Hesabi square, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Approval date
2018-09-23, 1397/07/01
Ethics committee reference number
IR.ZAUMS.REC.1397.254
Health conditions studied
1
Description of health condition studied
Contrast induced nephropathy
ICD-10 code
T80.8
ICD-10 code description
Other complications following infusion, transfusion and therapeutic injection
Primary outcomes
1
Description
Serum creatinine level altration
Timepoint
Serum creatinine levels are measured on the first day (day before the procedure) and 48 hours after exposure.
Method of measurement
creatinine test
Secondary outcomes
1
Description
incidence of CIN
Timepoint
48 h post exposure contrast media
Method of measurement
creatinine test
Intervention groups
1
Description
Intervention group: Group II was received Atorvastatin 80mg before coronary procedures (Atorvastatin 80 mg).
Category
Prevention
2
Description
Intervention group: Group III was administered N-acetylcysteine orally as a total dose of 1200 mg before and 600 mg after the coronary procedure (NAC 1800 mg).
Category
Prevention
3
Description
Intervention group: Group IV was prescribed 80 mg of Atorvastatin before the coronary procedure plus N-acetylcysteine as a sum of 1200 mg before and 600 mg after the coronary procedure (Atorvastatin 80 mg plus NAC 1800 mg).
Category
Prevention
4
Description
Control group: Group I was considered as control.They received neither Atorvastatin nor N-acetylcysteine before Coronary procedures.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali-ebn Abitaleb hospital
Full name of responsible person
Saeed Keshtkar
Street address
Ali-ebn Abitaleb hospital, Salamat Blvd., Khalij Fars high way
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
s.keshtkar20@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Nour Mohammad Bakhshani
Street address
Zahedan University of Medical Sciences, Dr Hesabi square
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Phone
+98 54 3329 5717
Email
parcomss97@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research and technology department
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
Zahedan University of Medical Sciences
Full name of responsible person
Saeed Keshtkar
Position
general practitioner
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Zahedan University of Medical Sciences, Dr Hesabi square, Zahedan
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Phone
+98 54 3329 5717
Email
s.keshtkar20@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Saeed Keshtkar
Position
general practitioner
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Zahedan University of Medical Sciences, Dr Hesabi square, Zahedan
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Phone
+98 54 3329 5717
Email
s.keshtkar20@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Saeed Keshtkar
Position
general practitioner
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Zahedan University of Medical Sciences, Dr Hesabi square, Zahedan
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Phone
+98 54 3329 5717
Email
s.keshtkar20@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