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Completed

NCT Number: NCT00926562

A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients

The investigators intend to find out which contrast agent has less kidney toxicity in renal impaired patients undergoing cardiac angiography or percutaneous coronary intervention (PCI).

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Key information

Conditions

Kidney Failure, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing CHAO-YANG Hospital, Beijing, Beijing Municipality, China

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About this study

In the diagnosis and treatment of coronary heart disease, patients should undergo cardiac angiography or percutaneous coronary intervention (PCI). In those procedures, the investigators should use the contrast media, and it may cause kidney toxicity especially in the patients with chronic renal insufficiency.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years old or older
  • Plan to undergo Cardiac Catheterization
  • Signed ICF
  • eGFR: 30~59 mL/min/1.73m2

Exclusion criteria

  • Pregnancy
  • Under dialysis
  • Conditions interfering with Cardiac Catheterization
  • Participation in other trials
  • Allergic to X-ray contrast media
  • Administration of any investigational drug within the previous 30 days
  • Intra-arterial or intravenous administration of iodinated contrast medium from 7 days before to 72 hours after the administration of study drug
  • Left ventricular ejection fraction (LVEF) less than 30% by ultrasound examination
  • Intake of any nephrotoxic medications 24 hours before or after the administration of study drug

Treatment and study plan

Iopromide (Ultravist)

Drug

Iopromide (contrast agent), 370 mgl/ml, an nonionic, monomeric, LOCM

Other names: Ultravist

Iodixanol (Visipaque)

Drug

Iodixanol (contrast agent) 320 mgl/ml, a nonionic, dimeric, IOCM

Other names: Visipaque

Primary outcomes

  1. Proportion of patients exhibiting a relative increase in serum creatinine >= 50% from baseline.

    Time frame: day 3 postreatment

Secondary outcomes

  1. Proportion of patients developing acute renal failure.

    Time frame: day 30 postreatment

  2. Incidence of a postdose SCr increase ≧25%, a postdose SCr increase ≧1mg/dL, a postdose SCr increase ≧0.5mg/dL, a postdose eGFR decrease ≧25%

    Time frame: days 3

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

A Randomized, Double-blinded Comparison of Iopromide and Iodixanol in Renally Impaired Patients Undergoing Cardiac Catheterization

Acronym: DIRECT

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Jun 23, 2009
Registry last updated
Jun 27, 2011

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

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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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