Patients With Renal Impairment Undergoing CT

Bracco

Status and phase: Completed; Phase 4

Conditions: Contrast Induced Nephropathy

Treatments: Drug: Iopamidol 370 mgI/mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT00292487

IOP107

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind