NCT00209417

Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography

GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 656 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Renal Insufficiency
• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Iodixanol 320-Arm 1
DRUG	Iopamidol 300-Arm 2

Timeline

• Start date: 2005-06-01
• Primary completion: 2011-05-01
• Completion: 2011-07-01
• First posted: 2005-09-21
• Last updated: 2014-10-17
• Results posted: 2014-10-10

Locations

2 sites across 2 countries: United States, United Kingdom