Status:
COMPLETED
Comparative Investigation of Intravenously Administered Omnipaque and Isovue: Effects on Serum Creatinine Concentration in Outpatients
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
GE Healthcare
Conditions:
Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine if one CT contrast agent (medication injected into a vein; used in CT examinations to help produce clearer images) is safer to use than another. This study wi...
Detailed Description
For patients without known kidney disease, it is exceptionally rare for the administration of CT contrast agents to injure the kidneys, and those rare injuries that do occur are almost always temporar...
Eligibility Criteria
Inclusion
- Patients 18 years of age and older
- Patients referred for a contrast-enhanced CT examination. Such contrast- enhanced CT examinations include, but are not limited to, certain examinations of the head, neck, chest, abdomen, pelvis, etc.
Exclusion
- Patients less than age of 18 years of age
- Pregnant patients
- Patients unable to provide written informed consent
- Patients in whom there are contraindications to the administration of intravenous contrast material (as detailed in out Department of Radiology intravenous contrast material use guidelines), including renal contraindications (such as a University of Michigan laboratory record of most recent serum creatinine concentration of \>1.5 mg/dl or an estimated glomerular filtration rate (EGFR) \<60 ml/min); if no serum creatinine is available, patients will be receive contrast material based on departmental guidelines
- Patients who are undergoing therapy with agents purported to reduce the risk of CIN (such as acetylcysteine, theophylline, or intravenous hydration)
- Patients who are unable to provide the follow-up serum creatinine concentration measurements
- Patients undergoing CT examinations that utilize a higher concentration of iodine (for example, 370 mg I/ml contrast material)
- Patients who have experienced allergic-like reactions to contrast; including patients who receive corticosteroid/antihistamine premedication to reduce the risk of an acute allergic-like reaction
- Patients who do not receive the study criterion for dose of contrast material; and patients in whom a contrast extravasation of more than 5 ml occurs (so that it is not possible to determine how much contrast material the patient received as a direct intravenous injection)
- Patients participating in other investigational drug, contrast material, or device trials
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
413 Patients enrolled
Trial Details
Trial ID
NCT00734357
Start Date
October 1 2009
End Date
October 1 2012
Last Update
June 13 2014
Active Locations (1)
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1
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109