Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction
- Registration Number
- NCT01580046
- Lead Sponsor
- Yong Huo
- Brief Summary
The purpose of this study is to compare renal toxicity of Iodixanol and Iopromide in patients with renal dysfunction.
- Detailed Description
The study is designed to compare renal toxicity of Iodixanol and Iopromide after coronary angiography or percutaneous coronary intervention (PCI) in patient with Chronic Kidney Disease, considering original renal function and adequate hydration. The risk of varying degree of renal impairment, changes of serum Cys C level will also be evaluated.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- Provides written Informed Consent and is willing to comply with protocol requirements
- Is referred for cardiac angiography, with or without PCI
- Has a documented predose serum creatinine level of 1.5～3.5 mg/dl for men and 1.3～3.0 mg/dl for women
- Serum creatinine levels of twice tests conform with the baseline criteria, and the difference of twice serum creatinine tests is not more than 30%(first test: within 3 month,prior to enrollment; second test: at enrollment)
- Has a history of hypersensitivity to iodine-containing compounds
- Has end-stage renal disease
- Has kidney transplantation
- Has creatinine clearance rates >60 ml/min in last 3 months
- Has acute coronary syndrome with heart failure(above class II in accordance with Killip or class III in accordance with the classification of the New York Heart Association (NYHA)) and shock
- Patients with cancer
- Has diabetes with serious complications, other kidney organs
- Patients with serious blood system disease
- Heart failure [class III~Ⅳ in accordance with the classification of the New York Heart Association (NYHA) and (or) pulmonary edema]
- Patients with hepatic insufficiency[3 times as ALT and (or) AST normal reference value limit]
- Has received an iodinated contrast agent within 14 days prior to the administration of the study agent
- Is scheduled to receive an iodinated contrast agent within 7 days after administration of the study agent
- Has acute renal failure or end-stage renal disease requiring dialysis in the past 3 months
- Use of 3 days continuously nonsteroidal anti-inflammatory drugs within 1 week of the procedure
- Patients with hypotension [(SBP<80 mmHg for over 1h and needing Medication or intraaortic balloon counterpulsation(IABP) ]
- Uncontrolled condition of hyperthyroidism
- pregnancy or lactation
- Is planned to receive the drugs without permission in this protocol
- Participating in another intervention research study in last 3 months
- legally incapacitated or limitations
- Any other conditions not suitable to be enrollment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Iodixanol iodixanol - iopromide iopromide -
- Primary Outcome Measures
Name Time Method to evaluate the change in Glomerular Filtration Rate levels by Estimated Glomerular Filtration Rate days 3 and 7
- Secondary Outcome Measures
Name Time Method In each group(Iodixanol group and Iopromide group), the proportion of patients exhibiting an increases of serum creatinine in different range(<10%,10%~25%, and ≥25%), comparing with baseline level. days 3 and 7 Changes of Cystatin C level from baseline days 1 and 3 Incidence of hemodialysis days 3 and 7
Trial Locations
- Locations (19)
The First Affiliated Hospital Of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
Pla Navy General Hospital
🇨🇳Beijing, China
Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
Xinqiao Hospital, Third Military Medical University
🇨🇳Chongqing, China
The Central Hospital Of China Aerospace Corporation
🇨🇳Beijing, China
Peking University People's Hospital
🇨🇳Beijing, China
Shanxi Cardiovascular Hospital
🇨🇳Taiyuan, Shanxi, China
Henan Provincial People's Hospital
🇨🇳Luoyang, Henan, China
The Second Affiliated Hospital To Nanchang University
🇨🇳Nanchang, Jiangxi, China
The Affiliated Hospital Of Medical College Qingdao University
🇨🇳Qingdao, Shandong, China
Renji Hospital ，Shanghai Jiao Tong University School Of Medicine
🇨🇳Shanghai, China
Chinese PLA General Hospital
🇨🇳Beijing, China
Guangdong Academy Of Medical Sciences Guangdong General Hospital
🇨🇳Guangzhou, Guangdong, China
The People's Hospital Of Hebei Province
🇨🇳Shijiazhuang, Hebei, China
The People's Hospital Of Liaoning Province
🇨🇳Shenyang, Liaoning, China
Shanghai First People's Hospital
🇨🇳Shanghai, China
Shanghai Chest Hospital Affiliated To Shanghai Jiaotong University
🇨🇳Shanghai, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China