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Evaluating the Protective Effect of Pentoxifylline on Contrast Induced Nephropathy

Information source: Shiraz University of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nephropathy

Intervention: Pentoxifylline (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Shiraz University of Medical Sciences

Official(s) and/or principal investigator(s):
Jamshid Roozbeh, Nephrologist, Study Chair, Affiliation: Shiraz Unievrsity of Medical Sciences, Shiraz, Iran

Overall contact:
Jamshid Roozbeh, Nephrologist, Phone: +98 711 6474316, Email: roozbehj@hotmail.com

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 mē) 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.

Clinical Details

Official title: Evaluating the Protective Effect of Pentoxifylline on Contrast Induced Nephropathy

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Serum Creatinine

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Jamshid Roozbeh, Nephrologist, Phone: +98 711 6474316, Email: roozbehj@hotmail.com

University Hospitals, Shiraz, Fars, Iran, Islamic Republic of; Recruiting
Jamshid Roozbeh, Nephrologist, Phone: +98 711 6474316, Email: roozbehj@hotmail.com
Jamshid Roozbeh, Nephrologist, Principal Investigator
Vahideh Yavari, M.D., Sub-Investigator
Additional Information

Starting date: April 2011
Last updated: November 8, 2011

Page last updated: August 23, 2015

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