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
Name Time Method Increase in SCr at 48-72 hours post dose
- Secondary Outcome Measures
Name Time Method 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