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Evaluating the Protective Effect of Pentoxifylline on Contrast Induced Nephropathy

Evaluating the Protective Effect of Pentoxifylline on Contrast Induced Nephropathy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01469624
Enrollment
Unknown
Registered
2011-11-10
Start date
2011-04-30
Completion date
2012-06-30
Last updated
2011-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephropathy

Keywords

Contrast Induced Nephropathy, Pentoxifylline, PCI

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.

Interventions

DRUGPentoxifylline

pentoxifylline 400 mg PO three times a day for 24 hours before and 24 hours after PCI

Sponsors

Shiraz University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frame
Serum Creatinine48 hours after PCI

Countries

Iran

Contacts

Primary ContactJamshid Roozbeh, Nephrologist
roozbehj@hotmail.com+98 711 6474316
Backup ContactVahideh Yavari, M.D.
yavariv@sums.ac.ir+98 711 6474316

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026