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

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

656 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Renal Insufficiency Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Iodixanol 320-Arm 1

Iodixanol 320 mg I/mL

Group Type ACTIVE_COMPARATOR

Iodixanol 320-Arm 1

Intervention Type DRUG

Iopamidol 300-Arm 2

Iopamidol 300 mg I/mL

Group Type ACTIVE_COMPARATOR

Iopamidol 300-Arm 2

Intervention Type DRUG

Interventions

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Iodixanol 320-Arm 1

Intervention Type DRUG

Iopamidol 300-Arm 2

Intervention Type DRUG

Other Intervention Names

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Visipaque Isovue

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No