Based on antioxidant effect of omega-3 polyunsaturated fatty acids and the role of free radicals in the pathogenesis of CIN, as well as a higher risk of CIN in patients with chronic kidney disease (CKD), this study is aimed to assess the effect of omega-3 in the prevention of CIN in CKD patients undergoing PCI. Inclusion criteria included chronic kidney disease with GFR 15- 60 ml/min/1.73 m2, the ages of 18 to 80 years, and patients undergoing elective PCI. The patients who treated with N-acetyl cysteine or receiving vitamin C before PCI were excluded. Eighty patients with CKD who are candidate for elective PCI will be randomly assigned into two groups. The intervention group will receive 2.5 g single dose of omega-3 plus standard CIN preventive therapy (hydration) 12 hrs before PCI whereas the control group will just receive standard regimen. Cystanin C and creatinine will be assessed before and 24 hrs after PCI as a primary outcome. Only analysts are blinded in this study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016031320441N3
Registration date:2016-04-29, 1395/02/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-29, 1395/02/10
Registrant information
Name
Farzaneh Foroughinia
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3635 9357
Email address
foroughinia@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences, International branch
Expected recruitment start date
2015-09-30, 1394/07/08
Expected recruitment end date
2016-12-30, 1395/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Role of Omega-3 in the prevention of contrast-induced nephropathy
Public title
The role of Omega-3 polyunsaturated fatty acids in the prevention of contrast-induced nephropathy (CIN) after percutaneous coronary intervention (PCI) in chronic kidney disease (CKD) patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria included chronic kidney disease with GFR 15- 60 ml/min/1.73 m2, the ages of 18 to 80 years, and patients undergoing elective PCI. Exclusion criteria: Pretreatment with N-acetyl cystein or intravenous vitamin C; sensitivity or tolerance to ASA or Clopidogrel or omega-3; sever adverse effects to drugs
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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 committe of Shiraz University of Medical Sciences
Street address
Zand avenue, Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2016-03-06, 1394/12/16
Ethics committee reference number
IR.SUMS.REC.1394.207
Health conditions studied
1
Description of health condition studied
renal disease
ICD-10 code
N14.1
ICD-10 code description
Nephropathy induced by other drugs, medicaments and biological substances
Primary outcomes
1
Description
cystatin C
Timepoint
24 hours after PCI
Method of measurement
kit
2
Description
serum creatinine
Timepoint
24 hours after PCI
Method of measurement
kit
Secondary outcomes
1
Description
CIN occurrence
Timepoint
24 hrs after PCI
Method of measurement
based on cystatin C
Intervention groups
1
Description
Intervention: omega-3 12hrs before PCI plus standard CIN preventive therapy (hydration)
Category
Prevention
2
Description
Control: just standard CIN preventive therapy (hydration)
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Heart Cente
Full name of responsible person
Street address
City
Shiraz
2
Recruitment center
Name of recruitment center
Alzahra Heart Center
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences, International branch
Full name of responsible person
Ali Poostforoosh Fard
Street address
Shiraz University of Medical Sciences building, Zand avenue
City
Shiraz
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, Shiraz University of Medical Sciences, International branch
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
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Foroughinia
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Pharmacy, Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
00
Fax
Email
farzanehforoughinia@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Foroughinia
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Pharmacy, Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
00
Fax
Email
farzanehforoughinia@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Foroughinia
Position
Assistant Profesoor
Other areas of specialty/work
Street address
Faculty of Pharmacy, Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
00
Fax
Email
farzanehforoughinia@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)