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Patients With Renal Impairment Undergoing CT

Phase 4
Completed
Conditions
Contrast Induced Nephropathy
Registration Number
NCT00292487
Lead Sponsor
Bracco Diagnostics, Inc
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
150
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Increase in SCr at 48-72 hours post dose
Secondary Outcome Measures
NameTimeMethod
Compare efficacy of key vessels
Compare incidence of delayed hypersensitivity type reactions
Compare changes in heart rate

Trial Locations

Locations (1)

Bracco Diagnostics, Inc

🇺🇸

Princeton, New Jersey, United States

Bracco Diagnostics, Inc
🇺🇸Princeton, New Jersey, United States

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