Evaluating the Protective Effect of Pentoxifylline on Contrast Induced Nephropathy

Nephropathy Clinical Trial

Official title:

Evaluating the Protective Effect of Pentoxifylline on Contrast Induced Nephropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01469624
• Other study ID #: 89-01-01-2507
• Status: Recruiting
• Phase: N/A
• First received: October 25, 2011
• Last updated: November 8, 2011
• Start date: April 2011
• Est. completion date: June 2012

Study information

• Verified date: November 2011
• Source: Shiraz University of Medical Sciences
• Contact: Jamshid Roozbeh, Nephrologist
• Phone: +98 711 6474316
• Email: roozbehj[@]hotmail.com
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Kidney Diseases
• Nephropathy

Intervention

Drug:
• Pentoxifylline
pentoxifylline 400 mg PO three times a day for 24 hours before and 24 hours after PCI

Locations

Country	Name	City	State
Iran, Islamic Republic of	University Hospitals	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Creatinine		48 hours after PCI	No