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Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography

NCT00209417 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 656

Last updated 2014-10-17

Study results available
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Summary

It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.

Conditions

Interventions

DRUG

Iodixanol 320-Arm 1

DRUG

Iopamidol 300-Arm 2

Sponsors & Collaborators

  • ABX CRO

    collaborator OTHER

  • Examination Management Services Inc.

    collaborator INDUSTRY

  • Covance

    collaborator INDUSTRY

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Averion International Corporation

    collaborator INDUSTRY

  • GE Healthcare

    lead INDUSTRY

Principal Investigators

  • Judith A Johnson, MS, MBA · GE Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2011-05-31
Completion
2011-07-31

Countries

  • United States
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00209417 on ClinicalTrials.gov