Introduction:
Contrast induced nephropathy (CIN) is a pathologic process in the kidney that may happen after exposure to iodinated media. CIN is clinically defined as a rise in serum creatinine of greater than 25% or more than 0.5 mg/dl within a period of 72 hours of receiving intravenous contrast. Percutaneous coronary intervention provides a high risk condition for incidence of CIN even in patients with normal renal function. Pentoxifylline (PTX) with a variety of mechanisms may prevent CIN.
Materials and methods:
Between April 5th, 2011 and February 20th, 2012, all consecutive eligible patients referred for elective percutaneous coronary intervention were asked to take part in the study. Eligibility was defined as the age between 18 and 65 years and baseline serum creatinine≤1.5 mg/dl. The patients were randomly allocated to two groups either receiving saline or saline plus pentoxifylline 400 mg orally three times a day for 48 hours. Serum creatinine, was measured 24 hours prior to the procedure and 48 hours thereafter. The primary endpoint was occurrence of CIN defined as 25% rise in serum creatinine 48 hours after the procedure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011135161N1
Registration date:2012-07-25, 1391/05/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-07-25, 1391/05/04
Registrant information
Name
Vahideh Yavari
Name of organization / entity
Shiraz University of Medical Sciences, Shiraz, Iran
Country
Iran (Islamic Republic of)
Phone
+98 71 1646 7125
Email address
yavariv@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellery of Research and Technology, Shiraz University of Medical Sciences, Shiraz, Iran
Expected recruitment start date
2011-04-05, 1390/01/16
Expected recruitment end date
2012-02-20, 1390/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Protective Effect of Pentoxifylline on Contrast Induced Nephropathy
Public title
Pentoxifylline and Contrast Induced Nephropathy
Purpose
Prevention
Inclusion/Exclusion criteria
Eligibility was defined as the age between 18 and 65 years and baseline serum creatinine≤1.5 mg/dl. Exclusion criteria were acute myocardial infarction, congestive heart failure, hemodynamic instability during or after procedure, known allergy or previous administration of pentoxifylline and use of concomitant nephrotoxic agents and diuretics.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
199
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
Committee of Ethics in Medical Researches, Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Research Affairs Management Office
24 hours before intervention and 48 hours after PCI
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention arm: Pentoxifylline (Trental) 400 mg PO three times a day for 24 hours before and 24 hours after PCI+1 ml/kg/h of 0.9 saline for 6 hours prior to and 6 hours after the procedure
Category
Prevention
2
Description
Control arm: 1 ml/kg/h of 0.9 saline for 6 hours prior to and 6 hours after PCI
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar hospital
Full name of responsible person
Dr. Mohammad Ali Ostovan
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research Affairs, Shiraz University of Medical Sciences
Full name of responsible person
Dr.Gholam Reza Hatam
Street address
Vice-chancellor for Research Affairs, Shiraz University of Medical Sciences
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 Affairs, Shiraz 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
Shiraz Nephro-urology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
Full name of responsible person
Jamshid Roozbeh
Position
Professor of Nephrology
Other areas of specialty/work
Street address
Shiraz Nephro-urology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 1647 4316
Fax
Email
roozbehj@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz Nephro-urology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
Full name of responsible person
Jamshid Roozbeh
Position
Professor of Nephrology
Other areas of specialty/work
Street address
Shiraz Nephro-urology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 1647 4316
Fax
Email
roozbehj@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences, Shiraz, Iran
Full name of responsible person
Vahideh Yavari
Position
Internal Medicine Resident/M.D.
Other areas of specialty/work
Street address
Namazi Teaching Hospital, Department of Internal Medicine
City
Shiraz
Postal code
Phone
+98 71 1647 4316
Fax
Email
yavariv@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)