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

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Study First Submitted: 2006-02-14
• Study First Submitted QC: 2006-02-14
• Study First Posted: 2006-02-16
• Status Verified: 2006-08
• Last Update Submitted: 2012-02-07
• Last Update Posted: 2012-02-08

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 incidence of delayed hypersensitivity type reactions
Compare changes in heart rate
Compare efficacy of key vessels

Trial Locations

Locations (1)

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