A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients

Phase 4

Completed

• Conditions: Kidney Failure, Chronic
• Interventions: Drug: Iodixanol (Visipaque); Drug: Iopromide (Ultravist)

• Registration Number: NCT00926562
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-06-19
• Study First Submitted QC: 2009-06-22
• Study First Posted: 2009-06-23
• Primary Completion: 2010-12
• Study Completion: 2011-05
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-24
• Last Update Posted: 2011-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 592

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iodixanol	Iodixanol (Visipaque)	Drug: Visipaque 320 mgl/ml, injection of intra-artery
Iopromide	Iopromide (Ultravist)	Drug: Ultravist 370 mgl/ml, injection of intra-artery during cardiac interventional operation

Primary Outcome Measures

Name	Time	Method
Proportion of patients exhibiting a relative increase in serum creatinine >= 50% from baseline.	day 3 postreatment

Secondary Outcome Measures

Name	Time	Method
Proportion of patients developing acute renal failure.	day 30 postreatment
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%	days 3

Trial Locations

Locations (19)

Beijing CHAO-YANG Hospital; 🇨🇳 Beijing, Beijing, China

General Hospital of Armed Police Forces; 🇨🇳 Beijing, Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Shi Jing Shan Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Hospital; 🇨🇳 Beijing, Beijing, China

Chinese PLA general hospital; 🇨🇳 Beijing, Beijing, China

Henan Provincial People's Hospital; 🇨🇳 Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Wuhan Asia Heart Hospital; 🇨🇳 Wuhan, Hubei, China

The Second Hospital of Xiangya; 🇨🇳 Changsha, Hunan, China

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