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Comparison of N-acetylcysteine, Ascorbic acid and Normal saline effect in prevention of contrast-induced nephropathy on the patient’s undergone coronary angiography

Protocol summary

Summary
Objectives: Considering the crucial role of appropriate preventative strategies in reducing the rate of contrast induced nephropathy (CIN) occurrence and its related morbidity and mortality, the effect of N-acetylcysteine (NAC), Ascorbic Acid (AA) and normal Saline will be investigated in the patient’s undergone coronary angiography. Design: In this randomized single blind, clinical trial, Setting and conduct : 120 patients scheduled for elective coronary angiography with serum creatinine level more than 1.5mg/dl or GFR more than or equal 60 will be selected by convenience method and patients with Oliguria (<400cc/24hours), severe heart failure with left ventricular ejection fraction (LVEF) < 35%, contrast-agent hypersensitivity, pregnancy, lactation, acute renal failure, , Vitamin C supplements will exclude . Intervention : Selected patients will be allocated in three treatment groups randomly to receive oral NAC(600mg/BID) plus normal saline (100ml/hour) [group A] ,oral ascorbic acid (250 mg/BID) plus normal saline (100ml/hour) [group B] and normal saline (100ml/hour) [group C], respectively. Main outcome measures: Occurrence of CIN will be evaluated based of serum creatinine (Cr) and glomerular filtration rate (GFR) in three studied groups, before and 72hours after angiography procedure.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015050722134N1
Registration date: 2015-06-16, 1394/03/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-06-16, 1394/03/26
Registrant information
Name
Mahtab Keshvari
Name of organization / entity
Cardiovascular Institution
Country
Iran (Islamic Republic of)
Phone
+98 913 781 0322
Email address
mkeshvari@crc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Shahrekord University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of N-acetylcysteine, Ascorbic acid and Normal saline effect in prevention of contrast-induced nephropathy on the patient’s undergone coronary angiography
Public title
contrast-induced nephropathy and the patient’s undergone coronary angiography
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: creatinine level of >1.5mg/dl; glomerular filtration rate ( GFR) ≤ 60 Exclusion criteria: Oliguria (<400cc/24hours); severe heart failure with left ventricular ejection fraction (LVEF) < 35%; contrast-agent hypersensitivity; pregnancy; lactation; acute renal failure; Vitamin C supplements
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences, Blvarayt Ayatollah Kashani, Staff University, Building No. 2, Vice chancellor for research,Shahrekord
City
Shahrekord
Postal code
8815713471
Approval date
2010-05-18, 1389/02/28
Ethics committee reference number
934

Health conditions studied

1

Description of health condition studied
Acute nephritic syndrome
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Heart failure
ICD-10 code
I50
ICD-10 code description
Left ventricular failure

Primary outcomes

1

Description
creatinine
Timepoint
before and after angiography
Method of measurement
ELISA kit

2

Description
glomerular filtration
Timepoint
before and after angiography
Method of measurement
Were used average estimated glomerular filtration rate of clearance of endogenous or exogenous materials

Secondary outcomes

empty

Intervention groups

1

Description
group A:N-acetylcysteine ( NAC)(600mg/BID) plus normal saline (100ml/hour).for 72hours
Category
Treatment - Drugs

2

Description
group B: ascorbic acid (250 mg/BID) plus normal saline (100ml/hour). for 72 hours
Category
Treatment - Drugs

3

Description
group C :normal saline (100ml/hour). for 72 hours
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hajar hospital
Full name of responsible person
Dr. Amrolall Ebrahimi
Street address
Hajar hospital,Parastar street,Shahrekord
City
Shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Shahrekord University of Medical Sciences
Full name of responsible person
Mahmoud Mobasheri
Street address
Shahrekord University of Medical Sciences, Blvarayt Ayatollah Kashani, Staff University, Building No. 2, Vice chancellor for research, Shahrekord
City
Shahrekord
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,Shahrekord 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
Isfahan University of Medical Sciences
Full name of responsible person
Amrollah Ebrahimi
Position
Physician,Internist
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Azadi Square, Harjirib Street,Isfahan
City
Isfahan
Postal code
Phone
+98 913 117 1521
Fax
Email
a_ev11@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord university of Medical Sciences
Full name of responsible person
Ali Momeni
Position
Associated Professor of Nephrology
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Blvarayt Ayatollah Kashani, Staff University, Building No. 2, Vice chancellor for research,Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3333 0061
Fax
Email
dr.ali_momeny@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mahtab Keshvari
Position
MSc of physiology
Other areas of specialty/work
Street address
Cardiovascular Research Center, Jomhoori Square, Khorram Street,Isfahan
City
Isfahan
Postal code
Phone
00
Fax
Email
mahtabkeshvari87@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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