NCT01580046

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Yong Huo · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Kidney Failure, Chronic

Interventions

Type	Name	Description
DRUG	iodixanol	1. coronary angiography, 32gI/100ml, 40～60 ml once injection 2. left ventricular, aortic root and selective coronary angiography, 32gI/100ml, 30～60 ml once injection
DRUG	iopromide	coronary angiography, 370mgI/ml(0.769gIopromide/ml),5～8 ml once injection

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-04-18
• Last updated: 2013-10-16

Locations

19 sites across 1 country: China