Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction (RIPE)

Yong Huo

Status and phase

Unknown

Phase 4

Conditions

Kidney Failure, Chronic

Treatments

Drug: iopromide

Drug: iodixanol

Study type

Interventional

Funder types

Other

Identifiers

NCT01580046

XNK201201

Details and patient eligibility

About

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

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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