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OpenTrials
Completed

NCT Number: NCT00292487

Patients With Renal Impairment Undergoing CT

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.

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Key information

Conditions

Contrast Induced Nephropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bracco Diagnostics, Inc

Princeton, New Jersey, 08543, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iopamidol 370 mgI/mL

Drug

Primary outcomes

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

Secondary outcomes

  1. Compare incidence of delayed hypersensitivity type reactions

  2. Compare changes in heart rate

  3. Compare efficacy of key vessels

Sponsors and collaborators

Lead sponsor

Bracco Diagnostics, Inc

Industry

Registry information

Official study title

Isovue and Visipaque in Renally Impaired Patients Undergoing CT

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Feb 16, 2006
Registry last updated
Feb 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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