Evaluation of short-term effect of adding Silymarin versus placebo to standard treatment, in prevention of contrast induced nephropathy in patient undergoing coronary angiography
The aim of this study is to evaluate the efficacy of Silymarin in preventing contrast nephropathy. Patients with chronic stable angina who need to coronary angiography will be included. Patients with diabetes, kidney disease, acute infarction, or unstable angina will not be included. Study sample will be consisting of 200 patients referring for angiography to the Khorshid Hospital in Isfahan, Iran. Patients will receive either a single dose of silymarin tablet (280 mg) or placebo tablet 2 hours before administration of the contrast material. All patients will be hydrated with 0.9% sodium chloride (1 mL/kg/h) for 12 hours, started 6 hours before operation and continued to 6 hours after the procedure. In all cases, a non-ionic contrast media with low osmolality will be used. Primary outcome is occurrence of the contrast nephropathy which is defined as an increase in serum creatinine of equal or more than 0.5 mg/dL or equal or more than 25% of the baseline creatinine after 48 hours of contrast material injection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014051117648N1
Registration date:2015-04-13, 1394/01/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-04-13, 1394/01/24
Registrant information
Name
Zohreh Sedighifard
Name of organization / entity
Esfahan Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 0042
Email address
zohresf@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2015-01-10, 1393/10/20
Expected recruitment end date
2015-03-31, 1394/01/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of short-term effect of adding Silymarin versus placebo to standard treatment, in prevention of contrast induced nephropathy in patient undergoing coronary angiography
Public title
Effect of Silymarin in prevention of contrast nephropaty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: having chronic stable angina; indication of coronary angiograghy; willingness to participate.
Exclusion criteria: FBS >=100; eGFR < 60 cc/1.73m2; history of diabetes or kidney disease; having myocardial infarction, unstable angina, or cardiogenic shock; tacking contrast agent during one month before study.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
200
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
Isfahan University of Medical Sciences
Street address
Hezar Jerib Ave.
City
Isfahan
Postal code
Approval date
2015-01-10, 1393/10/20
Ethics committee reference number
393752
Health conditions studied
1
Description of health condition studied
Nephropathy
ICD-10 code
N14
ICD-10 code description
Nephropathy induced by other drugs, medicaments and biological substances
Primary outcomes
1
Description
Contrast induced nephropathy
Timepoint
48 hours after angiography
Method of measurement
Measuring serum creatinine level
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Patients in the intervention group will receive a single dose of silymarin tablet (280 mg) 2 hours before administration of the contrast material.
Category
Prevention
2
Description
Patients in the placebo group will receive placebo tablet 2 hours before administration of the contrast material.
Category
Placebo
3
Description
All patients will be hydrated with 0.9% sodium chloride (1 mL/kg/h) for 12 hours, started 6 hours before operation and continued to 6 hours after the procedure.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Khorshid Hospital
Full name of responsible person
Zohreh Sedighifard
Street address
Ostandari St., Khorshid Hospital
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Vice Chancellor of Research
Street address
Vice Chancellor of Research, Isfahan University of Medical Sciences, Hezar Jerib Ave.
City
Isfahan
Grant name
Grant code / Reference number
393752
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Zohreh Sedighifard
Position
Resident of Cardiology
Other areas of specialty/work
Street address
Chamran Hospital, Chamran Blv.
City
Isfahan
Postal code
Phone
+98 31 3260 0961
Fax
Email
zohresf@resident.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Farshad Roghani
Position
Professor of Cardiology
Other areas of specialty/work
Street address
Department of Cardiology, Isfahan University of Medical Sciences, Hezar Jerib Ave.
City
Isfahan
Postal code
Phone
+98 31 3261 1400
Fax
Email
roghani_int@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Zohreh Sedighifard
Position
Resident of Cardiology
Other areas of specialty/work
Street address
Chamran Hospital, Chamran Blv.
City
Isfahan
Postal code
Phone
+98 31 3260 0961
Fax
Email
zohresf@resident.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)