A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients

Chinese PLA General Hospital592 enrolled

Overview

The investigators intend to find out which contrast agent has less kidney toxicity in renal impaired patients undergoing cardiac angiography or percutaneous coronary intervention (PCI).

In the diagnosis and treatment of coronary heart disease, patients should undergo cardiac angiography or percutaneous coronary intervention (PCI). In those procedures, the investigators should use the contrast media, and it may cause kidney toxicity especially in the patients with chronic renal insufficiency.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

592

Conditions

Kidney Failure, Chronic

Interventions

Iopromide (Ultravist)DRUG

Iopromide (contrast agent), 370 mgl/ml, an nonionic, monomeric, LOCM

Iodixanol (Visipaque)DRUG

Iodixanol (contrast agent) 320 mgl/ml, a nonionic, dimeric, IOCM

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years old or older * Plan to undergo Cardiac Catheterization * Signed ICF * eGFR: 30\~59 mL/min/1.73m2 Exclusion Criteria: * Pregnancy * Under dialysis * Conditions interfering with Cardiac Catheterization * Participation in other trials * Allergic to X-ray contrast media * Administration of any investigational drug within the previous 30 days * Intra-arterial or intravenous administration of iodinated contrast medium from 7 days before to 72 hours after the administration of study drug * Left ventricular ejection fraction (LVEF) less than 30% by ultrasound examination * Intake of any nephrotoxic medications 24 hours before or after the administration of study drug

Locations (19)

Beijing CHAO-YANG Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Proportion of patients exhibiting a relative increase in serum creatinine >= 50% from baseline.

Time frame: day 3 postreatment

Secondary Outcomes

Proportion of patients developing acute renal failure.

Time frame: day 30 postreatment

Incidence of a postdose SCr increase ≧25%, a postdose SCr increase ≧1mg/dL, a postdose SCr increase ≧0.5mg/dL, a postdose eGFR decrease ≧25%

Time frame: days 3

Data from ClinicalTrials.gov

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