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Evaluating the Protective Effect of Pentoxifylline on Contrast Induced Nephropathy

Primary Purpose

Nephropathy

Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Pentoxifylline
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nephropathy focused on measuring Contrast Induced Nephropathy, Pentoxifylline, PCI

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All eligible consecutive patients who are admitted to the angiography center of university hospitals for PCI since April 2011 will be enrolled to enter the study.

Exclusion Criteria:

  • Serum creatinine above 1.5 mg/dl
  • Frank bleeding tendency
  • Those previously on pentoxifylline

Sites / Locations

  • University HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Test group

Control group

Arm Description

This group receives pentoxifylline

Outcomes

Primary Outcome Measures

Serum Creatinine

Secondary Outcome Measures

Full Information

First Posted
October 25, 2011
Last Updated
November 8, 2011
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01469624
Brief Title
Evaluating the Protective Effect of Pentoxifylline on Contrast Induced Nephropathy
Official Title
Evaluating the Protective Effect of Pentoxifylline on Contrast Induced Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Contrast induced nephropathy (CIN) is of great concern when using contrast media in the new era of medicine. CIN is defined as 25-50% relative increase, 0.5-1 absolute increase in serum creatinin value or 25% fall in GFR. The incidence of CIN is found to be 0% to 10% in general population and up to 50% in high risk population. High risk patients include those with chronic kidney disease (GFR<60 ml/min/1.73 m²) Diabetes Mellitus, congestive heart failure, anemia and advanced age. Amount and kind of contrast medium and decreased circulating blood volume are other important predictors of CIN. 50% of cases of CIN happen within 24 hours of contrast injection. Maximum creatinin levels are reached between 48-72 hours. It usually returns to previous levels in 7-10 days. Suggested mechanisms are renal vasoconstriction and tubular injury. N-acetylcysteine and hydration are proved to be protective against CIN and theophylline may have a role. In this study, it is hypothesized that pentoxifylline, a dimethylxanthine, can also protect renal cells from CIN. It has been observed that pentoxifylline improves oxygen delivery to ischemic tissues, diminishes oxidative damage to renal tissue and may also scavenge free radicals. Percutaneous coronary intervention is assumed a high risk procedure for developing CIN as the amount of contrast used in PCI is remarkable. Therefore, the patients undergoing PCI were selected for the trial. A prospective randomized trial will be conducted on patients undergoing PCI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephropathy
Keywords
Contrast Induced Nephropathy, Pentoxifylline, PCI

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized

8. Arms, Groups, and Interventions

Arm Title
Test group
Arm Type
Experimental
Arm Description
This group receives pentoxifylline
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Pentoxifylline
Other Intervention Name(s)
Trental by Sanofi-Aventis
Intervention Description
pentoxifylline 400 mg PO three times a day for 24 hours before and 24 hours after PCI
Primary Outcome Measure Information:
Title
Serum Creatinine
Time Frame
48 hours after PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All eligible consecutive patients who are admitted to the angiography center of university hospitals for PCI since April 2011 will be enrolled to enter the study. Exclusion Criteria: Serum creatinine above 1.5 mg/dl Frank bleeding tendency Those previously on pentoxifylline
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jamshid Roozbeh, Nephrologist
Phone
+98 711 6474316
Email
roozbehj@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Vahideh Yavari, M.D.
Phone
+98 711 6474316
Email
yavariv@sums.ac.ir
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamshid Roozbeh, Nephrologist
Organizational Affiliation
Shiraz Unievrsity of Medical Sciences, Shiraz, Iran
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospitals
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamshid Roozbeh, Nephrologist
Phone
+98 711 6474316
Email
roozbehj@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jamshid Roozbeh, Nephrologist
First Name & Middle Initial & Last Name & Degree
Vahideh Yavari, M.D.

12. IPD Sharing Statement

Learn more about this trial

Evaluating the Protective Effect of Pentoxifylline on Contrast Induced Nephropathy

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