Effects of Contrast Media on Subjects With Stable Reduced Renal Function Undergoing Contrast-Enhanced Computed Tomography
NCT ID: NCT00793182
Last Updated: 2019-03-06
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
6 participants
INTERVENTIONAL
2009-01-31
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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1
Ioversol 320 mgI/mL
Ioversol 320 mgI/mL
125 mL of Ioversol administered in the vein
2
Iodixanol 320 mgI/mL
Iodixanol 320 mgI/mL
125 mL of Iodixanol administered in the vein
Interventions
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Ioversol 320 mgI/mL
125 mL of Ioversol administered in the vein
Iodixanol 320 mgI/mL
125 mL of Iodixanol administered in the vein
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects scheduled for a clinically indicated CECT requiring 40 grams of iodine (125 mL)
* Subjects have an abnormal screening SCr that results in a calculated eGFR of \< 60 mL/min/1.73 m2 using the MDRD formula and acute causes for an elevation in SCr have been excluded
* Subjects have stable reduced renal function which is defined as an abnormal screening SCr measurement with a \< 15% difference from the oldest historical SCr measurement obtained within the proceeding 1 week to 12 weeks
* Subjects must provide written consent and agree to abide by the site and study requirements
Exclusion Criteria
* Subjects on dialysis
* Subjects received any investigational drug within 30 days of contrast administration or participated in an investigational study within 30 days prior to study enrollment
* Subjects have undergone a procedure using iodinated or gadolinium contrast agent within 7 days prior to contrast administration, or is scheduled to receive additional doses of contrast agents during the 48-72 hour post-study contrast administration
* Subjects in acute renal failure or have one or more known causes of acute renal failure
* Subjects have known or suspected unstable renal function
* Subjects scheduled for a surgical intervention or other procedure within 72 hours after the contrast administration
* Subjects taking NSAIDs (with the exception of ASA) and/or any type of diuretics who cannot discontinue these drugs post contrast administration and hold all subsequent doses until the 48-72 hour post contrast SCr has been drawn
* Subjects taking aminoglycosides
* Subjects known to have an organ transplantation
* Subjects have severe congestive heart failure (Class III-IV)
18 Years
ALL
No
Sponsors
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Guerbet
INDUSTRY
Responsible Party
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Principal Investigators
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Eddie Darton, MD
Role: STUDY_DIRECTOR
Mallinckrodt
Locations
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UAB Hospital
Birmingham, Alabama, United States
Radiology LTD
Tucson, Arizona, United States
Providence Hospital
Washington D.C., District of Columbia, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Maine Research Associates
Auburn, Maine, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, United States
University of Rochester Medical Center
Rochester, New York, United States
Wake Research Associates
Raleigh, North Carolina, United States
Radiology Consultants, Inc.
Youngstown, Ohio, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States
Trinity Clinic
Tyler, Texas, United States
Countries
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Other Identifiers
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1323-07-872
Identifier Type: -
Identifier Source: org_study_id
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