Princeton, New Jersey 08540

  • Diabetes Mellitus

Purpose:

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.


Study summary:

GEHC has decided not to provide this detail


Criteria:

Inclusion Criteria: - Patients with a combination of diabetes mellitus (type I or II) and renal impairment who are referred for a contrast-enhanced CT examination. Exclusion Criteria: - Concurrent administration of potentially nephroprotective or nephrotoxic drugs is not permitted. - Patients undergoing dialysis or kidney transplantation will not be included.


NCT ID:

NCT00209417


Primary Contact:

Study Director
Judith A Johnson, MS, MBA
GE Healthcare


Backup Contact:

N/A


Location Contact:

Princeton, New Jersey 08540
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 26, 2020

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