Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yong Huo

Criteria

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