A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients
- Conditions
- Kidney Failure, Chronic
- Interventions
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 592
- 18 years old or older
- Plan to undergo Cardiac Catheterization
- Signed ICF
- eGFR: 30~59 mL/min/1.73m2
- 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)
Tianjin Chest Hospital
🇨🇳Tianjin, Tianjin, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
China-Japan Union Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Beijing CHAO-YANG Hospital
🇨🇳Beijing, Beijing, China
General Hospital of Armed Police Forces
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
Chinese PLA general hospital
🇨🇳Beijing, Beijing, China
Beijing Shi Jing Shan Hospital
🇨🇳Beijing, Beijing, China
The Second Hospital of Xiangya
🇨🇳Changsha, Hunan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Wuhan Asia Heart Hospital
🇨🇳Wuhan, Hubei, China
The First Hospital of Jilin University
🇨🇳Changchun, Jinlin, China
Teda International Cardiovascular Hospital
🇨🇳Tianjin, Tianjin, China
Shanghai First People's Hospital
🇨🇳Shanghai, Shanghai, China
Changhai Hospital affiliated to the second millitary medical university
🇨🇳Shanghai, Shanghai, China
Renji Hospital affiliated to Shanghai Jiao Tong University
🇨🇳Shanghai, Shanghai, China
Sir Run Run Shaw Hospital affiliated to Zhejiang
🇨🇳Hangzhou, Zhejiang, China
The Second Hospital Affiliated to Zhejiang University
🇨🇳Hangzhou, Zhejiang, China