Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00209417
Status:
TERMINATED
Last Update Posted:
2014-10-17
First Post:
2005-08-24
Brief Title:
Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography
Sponsor:
GE Healthcare
Organization:
GE Healthcare
Study Overview
Official Title:
GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title
Status:
TERMINATED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Supported by preliminary interim analysis Not based on any safety signals in study or any quality issues that could affect efficacy of the product
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is well known that X-ray contrast media can affect kidney function in some patients especially when administered intra-arterially and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk It is widely accepted to use low-osmolar or iso-osmolar contrast media especially in patients at risk for contrast media-induced nephropathy However little is known about the intravenous use of X-ray contrast media in risk patients such as contrast-enhanced CT examinations The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media Due to the iso-osmolar feature it is expected less influence on renal function following administration of iodixanol A standard hydration procedure based on available guidelines will be given to all patients to prevent negative effects on the kidneys Serum creatinine SCr concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function
Detailed Description:
GEHC has decided not to provide this detail
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None