Comparative Investigation of Intravenously Administered Omnipaque and Isovue: Effects on Serum Creatinine Concentration in Outpatients
NCT00734357 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 413
Last updated 2014-06-13
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 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.
Conditions
Interventions
- 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.
Sponsors & Collaborators
-
GE Healthcare
collaborator INDUSTRY - lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-10-31
- Primary Completion
- 2011-10-31
- Completion
- 2012-10-31
Countries
- United States
Study Locations
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