Patients With Renal Impairment Undergoing CT

NCT ID: NCT00292487

Last Updated: 2012-02-08

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2006-02-28

Brief Summary

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The purpose of the study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue or Visipaque in patients with mild to moderate renal impairment who undergo a clinically indicated IV contrast-enhanced (multidetector computed tomography) MDCT of the liver or MDCT angiography of the lower extremities. Serum Creatinine (SCr) will be measured before and up to 48-72 hours post dose.

Detailed Description

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Conditions

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Contrast Induced Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Interventions

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Iopamidol 370 mgI/mL

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* referred for MDCT of liver or peripheral CTA
* stable baseline SCr of 1.5 - 2.5 mg/dL and/or calculated CrCl of 10-60 mL/min

Exclusion Criteria

* unstable renal function
* required prophylactic drugs to receive contrast (other than hydration)
* uncontrolled diabetes
* currently on dialysis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bracco Diagnostics, Inc

INDUSTRY

Sponsor Role lead

Principal Investigators

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Marie Morris

Role: STUDY_DIRECTOR

Bracco Diagnostics, Inc

Locations

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Bracco Diagnostics, Inc

Princeton, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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IOP107

Identifier Type: -

Identifier Source: org_study_id

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