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Evaluating the Protective Effect of Pentoxifylline on Contrast Induced Nephropathy

S

Shiraz University of Medical Sciences

Status

Unknown

Conditions

Nephropathy

Treatments

Drug: Pentoxifylline

Study type

Interventional

Funder types

Other

Identifiers

NCT01469624
89-01-01-2507

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups

Test group
Experimental group
Description:
This group receives pentoxifylline
Treatment:
Drug: Pentoxifylline
Control group
No Intervention group

Trial contacts and locations

1

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Central trial contact

Vahideh Yavari, M.D.; Jamshid Roozbeh, Nephrologist

Data sourced from clinicaltrials.gov

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