Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction

Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction-a Multicentre, Single Blind, Randomized Controlled, Prospective Trial

The purpose of this study is to compare renal toxicity of Iodixanol and Iopromide in patients with renal dysfunction.

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.

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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