Patients With Renal Impairment Undergoing CT

Bracco Diagnostics, Inc150 enrolled

Overview

The purpose of the study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue or Visipaque in patients with mild to moderate renal impairment who undergo a clinically indicated IV contrast-enhanced (multidetector computed tomography) MDCT of the liver or MDCT angiography of the lower extremities. Serum Creatinine (SCr) will be measured before and up to 48-72 hours post dose.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

150

Conditions

Contrast Induced Nephropathy

Interventions

Iopamidol 370 mgI/mLDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * referred for MDCT of liver or peripheral CTA * stable baseline SCr of 1.5 - 2.5 mg/dL and/or calculated CrCl of 10-60 mL/min Exclusion Criteria: * unstable renal function * required prophylactic drugs to receive contrast (other than hydration) * uncontrolled diabetes * currently on dialysis

Locations (1)

Bracco Diagnostics, Inc

Princeton, New Jersey, United States

Outcomes

Primary Outcomes

Increase in SCr at 48-72 hours post dose

Secondary Outcomes

Compare incidence of delayed hypersensitivity type reactions

Compare changes in heart rate

Compare efficacy of key vessels

Data from ClinicalTrials.gov

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