Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography
Stopped early · Phase 4
Conditions studied: Renal Insufficiency, Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT00209417
- Run by
- GE Healthcare
- People needed
- 656
- Starts
- 2005-06-01
- Expected to finish
- 2011-07-01
- Last updated by the study team
- 2014-10-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with a combination of diabetes mellitus (type I or II) and renal impairment who are referred for a contrast-enhanced CT examination.
You may not qualify if…
- Concurrent administration of potentially nephroprotective or nephrotoxic drugs is not permitted.
- Patients undergoing dialysis or kidney transplantation will not be included.
Where it is running
- GE Healthcare — Princeton, New Jersey, United States
- GE Healthcare — Amersham, United Kingdom
Full record on ClinicalTrials.gov
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