Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction

Unknown status
Trial end date:
Target enrollment:
Participant gender:
The purpose of this study is to compare renal toxicity of Iodixanol and Iopromide in patients with renal dysfunction.
Phase 4
Accepts Healthy Volunteers?
Lead Sponsor:
Yong Huo
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

- 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

- Use of 3 days continuously nonsteroidal anti-inflammatory drugs within 1 week of the

- 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