Status:
TERMINATED
Effects of Contrast Media on Subjects With Stable Reduced Renal Function Undergoing Contrast-Enhanced Computed Tomography
Lead Sponsor:
Guerbet
Conditions:
Renal Impairment
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the contrast-induced nephropathy (CIN) rate in subjects randomized to receive either Ioversol or Iodixanol for contrast-enhanced computed tomography.
Detailed Description
Contrast-induced nephropathy (CIN) is an acute decline in renal function after the administration of iodinated contrast agents. CIN is commonly defined as an increase in post contrast serum creatinine...
Eligibility Criteria
Inclusion
- Males and females 18 years of age or older
- 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
- Subjects previously entered into this study
- 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)
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00793182
Start Date
January 1 2009
End Date
June 1 2009
Last Update
March 6 2019
Active Locations (13)
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1
UAB Hospital
Birmingham, Alabama, United States, 35233
2
Radiology LTD
Tucson, Arizona, United States, 85711
3
Providence Hospital
Washington D.C., District of Columbia, United States, 20017
4
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61602