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Clinical Trial Protocol

Iranian Registry of Clinical Trials
17 Feb 2020

Evaluating the Protective Effect of Pentoxifylline on Contrast Induced

Nephropathy

Protocol summary Phone

+98 71 1646 7125
Summary Email address
Introduction: Contrast induced nephropathy (CIN) is a yavariv@sums.ac.ir
pathologic process in the kidney that may happen after
exposure to iodinated media. CIN is clinically defined as Recruitment status
a rise in serum creatinine of greater than 25% or more Recruitment complete
than 0.5 mg/dl within a period of 72 hours of receiving Funding source
intravenous contrast. Percutaneous coronary Vice-Chancellery of Research and Technology, Shiraz
intervention provides a high risk condition for incidence University of Medical Sciences, Shiraz, Iran
of CIN even in patients with normal renal function.
Pentoxifylline (PTX) with a variety of mechanisms may Expected recruitment start date
prevent CIN. Materials and methods: Between April 5th, 2011-04-05, 1390/01/16
2011 and February 20th, 2012, all consecutive eligible Expected recruitment end date
patients referred for elective percutaneous coronary 2012-02-20, 1390/12/01
intervention were asked to take part in the study. Actual recruitment start date
Eligibility was defined as the age between 18 and 65 empty
years and baseline serum creatinine≤1.5 mg/dl. The Actual recruitment end date
patients were randomly allocated to two groups either empty
receiving saline or saline plus pentoxifylline 400 mg Trial completion date
orally three times a day for 48 hours. Serum creatinine, empty
was measured 24 hours prior to the procedure and 48
hours thereafter. The primary endpoint was occurrence Scientific title
of CIN defined as 25% rise in serum creatinine 48 hours Evaluating the Protective Effect of Pentoxifylline on
after the procedure. Contrast Induced Nephropathy

Public title
General information Pentoxifylline and Contrast Induced Nephropathy
Purpose
Acronym
Prevention
IRCT registration information
IRCT registration number: IRCT201011135161N1 Inclusion/Exclusion criteria
Registration date: 2012-07-25, 1391/05/04 Eligibility was defined as the age between 18 and 65
Registration timing: retrospective years and baseline serum creatinine≤1.5 mg/dl.
Exclusion criteria were acute myocardial infarction,
congestive heart failure, hemodynamic instability during
Last update: or after procedure, known allergy or previous
Update count: 0 administration of pentoxifylline and use of concomitant
Registration date nephrotoxic agents and diuretics.
2012-07-25, 1391/05/04 Age
From 18 years old to 65 years old
Registrant information Gender
Name Both
Vahideh Yavari
Name of organization / entity Phase
Shiraz University of Medical Sciences, Shiraz, Iran N/A
Country Groups that have been masked
Iran (Islamic Republic of) No information

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Sample size Secondary outcomes

Target sample size: 199
Randomization (investigator's opinion) empty
Randomized
Randomization description Intervention groups
Blinding (investigator's opinion)
Single blinded 1
Blinding description
Description
Placebo Intervention arm: Pentoxifylline (Trental) 400 mg PO
Not used three times a day for 24 hours before and 24 hours after
Assignment PCI+1 ml/kg/h of 0.9 saline for 6 hours prior to and 6
Parallel hours after the procedure
Other design features Category
Prevention
Secondary Ids
2
empty
Description
Control arm: 1 ml/kg/h of 0.9 saline for 6 hours prior to
Ethics committees
and 6 hours after PCI
Category
1 Prevention

Ethics committee
Name of ethics committee Recruitment centers
Committee of Ethics in Medical Researches, Shiraz
University of Medical Sciences 1
Street address
Recruitment center
Shiraz University of Medical Sciences, Research
Name of recruitment center
Affairs Management Office
Kowsar hospital
City
Full name of responsible person
Shiraz Dr. Mohammad Ali Ostovan
Postal code Street address
Approval date City
2011-10-06, 1390/07/14 Shiraz
Ethics committee reference number
ct-90-2507
Sponsors / Funding sources

Health conditions studied 1

Sponsor
1 Name of organization / entity
Description of health condition studied Vice-chancellor for Research Affairs, Shiraz University
Contrast Induced Nephropathy of Medical Sciences
Full name of responsible person
ICD-10 code
Dr.Gholam Reza Hatam
N 17
Street address
ICD-10 code description
Vice-chancellor for Research Affairs, Shiraz University
Acute renal failure (includes acute renal impairment)
of Medical Sciences
City
Primary outcomes Shiraz
Grant name
Grant code / Reference number
1 Is the source of funding the same sponsor
Description organization/entity?
Serum creatinine Yes
Title of funding source
Timepoint
Vice-chancellor for Research Affairs, Shiraz University of
24 hours before intervention and 48 hours after PCI
Medical Sciences
Method of measurement
Proportion provided by this source
Blood test
100

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Public or private sector City

empty Shiraz
Domestic or foreign origin Postal code
empty Phone
Category of foreign source of funding +98 71 1647 4316
empty Fax
Country of origin Email
Type of organization providing the funding roozbehj@hotmail.com
empty Web page address

Person responsible for updating data

Person responsible for general inquiries
Contact
Contact
Name of organization / entity
Name of organization / entity
Shiraz University of Medical Sciences, Shiraz, Iran
Shiraz Nephro-urology Research Center, Shiraz
Full name of responsible person
University of Medical Sciences, Shiraz, Iran
Vahideh Yavari
Full name of responsible person
Position
Jamshid Roozbeh
Internal Medicine Resident/M.D.
Position
Other areas of specialty/work
Professor of Nephrology
Street address
Other areas of specialty/work
Namazi Teaching Hospital, Department of Internal
Street address
Medicine
Shiraz Nephro-urology Research Center, Shiraz
City
University of Medical Sciences, Shiraz, Iran
Shiraz
City
Postal code
Shiraz
Phone
Postal code
+98 71 1647 4316
Phone
+98 71 1647 4316
Fax
Fax Email
Email yavariv@sums.ac.ir
roozbehj@hotmail.com Web page address
Web page address
Sharing plan
Person responsible for scientific
Deidentified Individual Participant Data Set (IPD)
inquiries empty
Study Protocol
Contact
empty
Name of organization / entity
Statistical Analysis Plan
Shiraz Nephro-urology Research Center, Shiraz
empty
University of Medical Sciences, Shiraz, Iran
Informed Consent Form
Full name of responsible person
empty
Jamshid Roozbeh
Clinical Study Report
Position
empty
Professor of Nephrology
Analytic Code
Other areas of specialty/work
empty
Street address
Data Dictionary
Shiraz Nephro-urology Research Center, Shiraz
empty
University of Medical Sciences, Shiraz, Iran