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Evaluating the Protective Effect of Pentoxifylline on Contrast Induced Nephropathy

Sponsor
Shiraz University of Medical Sciences (Other)
Overall Status
Unknown status
CT.gov ID
NCT01469624
Collaborator
(none)
1
Location
2
Arms
14
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Evaluating the Protective Effect of Pentoxifylline on Contrast Induced Nephropathy
Study Start Date :
Apr 1, 2011
Anticipated Primary Completion Date :
Jun 1, 2012
Anticipated Study Completion Date :
Jun 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Test group

This group receives pentoxifylline

Drug: Pentoxifylline
pentoxifylline 400 mg PO three times a day for 24 hours before and 24 hours after PCI
Other Names:
  • Trental by Sanofi-Aventis

    		•
    No Intervention: Control group

    Outcome Measures

    Primary Outcome Measures

    1. Serum Creatinine [48 hours after PCI]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospitals Shiraz Fars Iran, Islamic Republic of

    Sponsors and Collaborators

    • Shiraz University of Medical Sciences

    Investigators

    • Study Chair: Jamshid Roozbeh, Nephrologist, Shiraz Unievrsity of Medical Sciences, Shiraz, Iran

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    jamshid roozbeh, Clinical Professor, Shiraz University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT01469624
    Other Study ID Numbers:
    • 89-01-01-2507
    First Posted:
    Nov 10, 2011
    Last Update Posted:
    Nov 10, 2011
    Last Verified:
    Nov 1, 2011
    Keywords provided by jamshid roozbeh, Clinical Professor, Shiraz University of Medical Sciences
    Contrast Induced Nephropathy
    Pentoxifylline
    PCI
    Additional relevant MeSH terms:
    Kidney Diseases
    Pentoxifylline

    Study Results

    No Results Posted as of Nov 10, 2011