Clinical trial NCT00209417: Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography
Official title: GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Renal Insufficiency
Diabetes Mellitus
Keywords: Iodixanol
Iopamidol
computed tomography
Patients with pre-existing renal impairment and diabetes
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: ABX CRO
name: Examination Management Services Inc.
name: Covance
name: Quintiles, Inc.
name: Averion International Corporation
First posted: 2005-09-21
Enrollment: 656
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

Eligibility 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.

Primary outcomes:
measure: Assessment of the Incidence Rate of Contrast Medium-Induced Nephropathy (CIN) Between Iodixanol and Iopamidol in Patients With Impaired Renal Function.
timeFrame: From baseline up to 3 days post contrast administration.
Secondary outcomes:
measure: Assessment of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-enhanced Multi-detector-row Helical Computed Tomography (MDCT) Examination.
timeFrame: Within 2, 3 and 7 days post contrast administration.
Other outcomes:
Locations:
city: Princeton
country: United States
facility: GE Healthcare
state: New Jersey
city: Amersham
country: United Kingdom
facility: GE Healthcare
Study officials:
affiliation: GE Healthcare
name: Judith A Johnson, MS, MBA
role: STUDY_DIRECTOR
References: