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Evaluating the Protective Effect of Pentoxifylline on Contrast Induced Nephropathy

NCT ID: NCT01469624

Last Updated: 2011-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Test group

This group receives pentoxifylline

Group Type EXPERIMENTAL

Pentoxifylline

Intervention Type DRUG

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

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pentoxifylline

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

Intervention Type DRUG

Other Intervention Names

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Trental by Sanofi-Aventis

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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jamshid roozbeh

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jamshid Roozbeh, Nephrologist

Role: STUDY_CHAIR

Shiraz Unievrsity of Medical Sciences, Shiraz, Iran

Locations

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University Hospitals

Shiraz, Fars, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Jamshid Roozbeh, Nephrologist

Role: CONTACT

[email protected]
+98 711 6474316

Vahideh Yavari, M.D.

Role: CONTACT

[email protected]
+98 711 6474316

Facility Contacts

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Jamshid Roozbeh, Nephrologist

Role: primary

[email protected]
+98 711 6474316

Other Identifiers

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89-01-01-2507

Identifier Type: -

Identifier Source: org_study_id