Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-28 @ 10:06 PM
Study NCT ID:
NCT00734357
Status:
COMPLETED
Last Update Posted:
2014-06-13
First Post:
2008-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Investigation of Intravenously Administered Omnipaque and Isovue: Effects on Serum Creatinine Concentration in Outpatients
Sponsor:
University of Michigan
Organization:
Study Overview
Official Title:
Comparative Investigation of Intravenously Administered Omnipaque and Isovue: Effects on Serum Creatinine Concentration in Outpatients
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
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 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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: