Evaluating the Protective Effect of Pentoxifylline on Contrast Induced Nephropathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Shiraz University of Medical Sciences.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
jamshid roozbeh, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01469624
First received: October 25, 2011
Last updated: November 8, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Nephropathy
Drug: Pentoxifylline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluating the Protective Effect of Pentoxifylline on Contrast Induced Nephropathy

Resource links provided by NLM:


Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • Serum Creatinine [ Time Frame: 48 hours after PCI ] [ Designated as safety issue: No ]

Study Start Date: April 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test group
This group receives pentoxifylline
Drug: Pentoxifylline
pentoxifylline 400 mg PO three times a day for 24 hours before and 24 hours after PCI
Other Name: Trental by Sanofi-Aventis
No Intervention: Control group

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01469624

Contacts
Contact: Jamshid Roozbeh, Nephrologist +98 711 6474316 roozbehj@hotmail.com
Contact: Vahideh Yavari, M.D. +98 711 6474316 yavariv@sums.ac.ir

Locations
Iran, Islamic Republic of
University Hospitals Recruiting
Shiraz, Fars, Iran, Islamic Republic of
Contact: Jamshid Roozbeh, Nephrologist    +98 711 6474316    roozbehj@hotmail.com   
Principal Investigator: Jamshid Roozbeh, Nephrologist         
Sub-Investigator: Vahideh Yavari, M.D.         
Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
Study Chair: Jamshid Roozbeh, Nephrologist Shiraz Unievrsity of Medical Sciences, Shiraz, Iran
  More Information

No publications provided

Responsible Party: jamshid roozbeh, Clinical Professor, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01469624     History of Changes
Other Study ID Numbers: 89-01-01-2507
Study First Received: October 25, 2011
Last Updated: November 8, 2011
Health Authority: Iran: Ethics Committee

Keywords provided by Shiraz University of Medical Sciences:
Contrast Induced Nephropathy
Pentoxifylline
PCI

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Pentoxifylline
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Cardiovascular Agents
Free Radical Scavengers
Antioxidants

ClinicalTrials.gov processed this record on September 22, 2014