Contrast Induced Nephropathy
Conditions
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.
Interventions
Sponsors
Bracco Diagnostics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in SCr at 48-72 hours post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare incidence of delayed hypersensitivity type reactions | — |
| Compare changes in heart rate | — |
| Compare efficacy of key vessels | — |
Countries
United States
Outcome results
None listed