This study designed for assess efficacy of ascorbic acid to prevention of contrast induced nephropathy in patients undergone coronary angiography in heart center Fatemeh Zahra hospital in sari town during 1392-93.
This study done as prospective randomized double blind clinical trail with control group.
Inclusion criteria:All patients admitted for coronary angiography in Mazandaran Heart Center in sari in 1392-93.
Exclusion criteria: End stage renal disease; creatinin above 3 or Glumerolar filtration rate below 30 ml/min; Administration of intra venues contrast media in last 6 days; use of ascorbic acid daily in last week before coronary angiography; sever hypertention ; severe heart failure (NYHA class 3-4)
320 patients entered ,with 160 in case and control group respectively.
Patients in case group underwent administration of 3 grams ascorbic acid at least 2 hour before procedure and then 2 grams in first night and morning after procedure .In control group patients gives placebo in same doses .All patients underwent hydration as standard protocol.
Serum creatinin measured one day before and then 3-5 days after coronary angiography .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015030918741N1
Registration date:2015-10-16, 1394/07/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-16, 1394/07/24
Registrant information
Name
Babak Bagheri
Name of organization / entity
Mazandaran university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3332 4002
Email address
bbagheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mazandaran University of Medical Sciences
Expected recruitment start date
2013-09-10, 1392/06/19
Expected recruitment end date
2015-02-01, 1393/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Ascorbic acid effectiveness in prevention of contrast mediated nephropathy in patients underwent coronary angiography
Public title
Vitamin C effectiveness in prevention of contrast mediated nephropathy in patients underwent coronary angiography
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: All the patients who underwent angiography and did not meet exclusion criteria
Exclusion criteria: End stage renal disease; creatinin above 3 or Glumerolar filtration rate below 30 ml/min; Administration of intra venues contrast media in last 6 days; use of ascorbic acid daily in last week before coronary angiography; sever hypertention ; severe heart failure (NYHA class 3-4)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
320
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 comittee of Mazandaran university of medical university
Street address
Juybar Avenue
City
Sari
Postal code
Approval date
2014-01-14, 1392/10/24
Ethics committee reference number
747
Health conditions studied
1
Description of health condition studied
Contrast-Induced Nephropathy
ICD-10 code
N 14.1
ICD-10 code description
Nephropathy induced by other drugs, medicaments and biological substances
Primary outcomes
1
Description
Nephropathy
Timepoint
One day befor and 3 to 5 days after angiography
Method of measurement
Measuring Creatinin and GFR with Cockcroft-Gault formula
Secondary outcomes
empty
Intervention groups
1
Description
In patient group,all patients will receive 3 gr chewing acid ascorbic (12 *250 mg powder) 2 hours befor angiography and then they will receive 2 gr in the first night and the next morning.
Category
Prevention
2
Description
In control group, patients will receive placebo.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Mazandaran Heart Center
Full name of responsible person
Nazanin Hanafi
Street address
Mazandaran Heart Center, Artesh BLVD, Imam Hossein square
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Deputy of research , Moallem Square
City
Sari
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 Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Babak Bagheri
Position
Assistant professor of Cardiology
Other areas of specialty/work
Street address
Mazandaran Heart Center , Artesh BLVD , Imam Hossein Square
City
Sari
Postal code
Phone
+98 113324002
Fax
Email
bbagheri@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical sciences
Full name of responsible person
Babak Bagheri
Position
Assistant professor of cardiology
Other areas of specialty/work
Street address
Mazandaran Heart Center , Artesh BLVD , Imam hossein BLVD
City
Sari
Postal code
Phone
+98 113324002
Fax
Email
bbagheri@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Babak Bagheri
Position
Assistant professor of cardiology
Other areas of specialty/work
Street address
Mazandaran Heart Center , Artesh BLVD , Imam hossein BLVD
City
Sari
Postal code
4818813771
Phone
+98 113324002
Fax
Email
bbagheri@mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)