Patients With Renal Impairment Undergoing CT

• Sponsor: Bracco Diagnostics, Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00292487
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Duration (Months): 15
• Patients Per Site Per Month: 10

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contrast Induced Nephropathy	Drug: Iopamidol 370 mgI/mL	Phase 4

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Diagnostic
• Official Title: Isovue and Visipaque in Renally Impaired Patients Undergoing CT
• Study Start Date: Nov 1, 2004
• Actual Primary Completion Date: Feb 1, 2006
• Actual Study Completion Date: Feb 1, 2006

Outcome Measures

Primary Outcome Measures

1. Increase in SCr at 48-72 hours post dose []

Secondary Outcome Measures

1. Compare incidence of delayed hypersensitivity type reactions []

2. Compare changes in heart rate []

3. Compare efficacy of key vessels []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bracco Diagnostics, Inc	Princeton	New Jersey	United States	08543

Sponsors and Collaborators

• Bracco Diagnostics, Inc

Investigators

• Study Director: Marie Morris, Bracco Diagnostics, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00292487
• Other Study ID Numbers: IOP107
• First Posted: Feb 16, 2006
• Last Update Posted: Feb 8, 2012
• Last Verified: Aug 1, 2006

• Additional relevant MeSH terms: Kidney Diseases

Study Results

No Results Posted as of Feb 8, 2012