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Sponsors and Collaborators: |
University of Michigan GE Healthcare |
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Information provided by: | University of Michigan |
ClinicalTrials.gov Identifier: | NCT00734357 |
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 will compare the safety of two widely-used, U.S. FDA approved contrast agents, Isovue and Omnipaque. The investigators hypothesize that there is no significant difference in the rates of contrast-induced nephrotoxicity (CIN) between these agents when the overall population consists of low-risk patients.
Condition | Intervention |
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Computerized Emission Tomography |
Procedure: Blood work |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | Comparative Investigation of Intravenously Administered Omnipaque and Isovue: Effects on Serum Creatinine Concentration in Outpatients |
Estimated Enrollment: | 500 |
Study Start Date: | June 2008 |
Arms | Assigned Interventions |
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Isovue Arm: Experimental
Subjects with a clinically scheduled CT examination will be given the contrast Isovue. The investigators of this study will determine which contrast medication subjects will receive using randomization.
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Procedure: Blood work
Prior to having the clinically scheduled CT examination the subject will have blood work drawn. This blood work will give the investigators a baseline value of the basic kidney function of the subject. They will then have blood work done again at 2 days and again at 3 days following the CT examination. Some patients, based on their blood work obtained at 2 and 3 days after the CT examination, will be asked to have blood work performed at 7 days after their CT examination.
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Omnipaque Arm: Experimental
Subjects with a clinically scheduled CT examination will be given the contrast Omnipaque. The investigators of this study will determine which contrast medication subjects will receive using randomization
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Procedure: Blood work
Prior to having the clinically scheduled CT examination the subject will have blood work drawn. This blood work will give the investigators a baseline value of the basic kidney function of the subject. They will then have blood work done again at 2 days and again at 3 days following the CT examination. Some patients, based on their blood work obtained at 2 and 3 days after the CT examination, will be asked to have blood work performed at 7 days after their CT examination.
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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 temporary (a week or two) and heal. Indeed, significant injuries are so rare that the kidney function in patients is not routinely checked after they receive CT contrast agents. There are many brands of contrast media in common use across the United States, and it has been thought in the past that all are similarly low in risk. The purpose of this study is to examine whether two different contrast materials might differ in their risk to the kidneys. We will perform a direct comparison of Omnipaque-300 (iohexol, 300 mg I/ml) and Isovue-300 (Iopamidol, 300 mg I/ml) low osmolality contrast agents to determine their relative CIN rates (as measured by serum creatinine concentration) in low-risk patients.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ravi Kaza | 734-763-4051 | ravikaza@umich.edu |
Contact: Jonathon Willatt | 734-647-0760 | jwillatt@umich.edu |
United States, Michigan | |
University of Michigan Hospital | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Ravi Kaza 734-763-4051 ravikaza@umich.edu |
Responsible Party: | University of Michigan Health System ( Ravi Kaza MD ) |
Study ID Numbers: | HUM00019769 |
Study First Received: | August 12, 2008 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00734357 History of Changes |
Health Authority: | United States: Institutional Review Board |
contrast ct cat scan kidney nephrotoxicity |