Evaluating the Protective Effect of Pentoxifylline on Contrast Induced Nephropathy
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
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Started Apr 2011
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 25, 2011
CompletedFirst Posted
Study publicly available on registry
November 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedNovember 10, 2011
November 1, 2011
1.2 years
October 25, 2011
November 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum Creatinine
48 hours after PCI
Study Arms (2)
Test group
EXPERIMENTALThis group receives pentoxifylline
Control group
NO INTERVENTIONInterventions
pentoxifylline 400 mg PO three times a day for 24 hours before and 24 hours after PCI
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Serum creatinine above 1.5 mg/dl
- Frank bleeding tendency
- Those previously on pentoxifylline
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals
Shiraz, Fars, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jamshid Roozbeh, Nephrologist
Shiraz Unievrsity of Medical Sciences, Shiraz, Iran
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
October 25, 2011
First Posted
November 10, 2011
Study Start
April 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
November 10, 2011
Record last verified: 2011-11