Contrast-medium Induced Nephrotoxicity in Patients Undergoing Coronary Angiography - Iodixanol Versus Iopromide

Phase 4

Completed

• Conditions: Chronic Renal Insufficiency; Coronary Angiography
• Interventions: Drug: contrast agent (iopromide); Drug: contrast agent (iodixanol)

• Registration Number: NCT00823628
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

In the treatment of coronary heart disease which is the major cause of heart attack, direct mechanical treatment with catheters such as the coronary angiography, coronary balloon intervention and stenting intervention are the mainstay of therapy in recent years. In that procedures, the investigators should use the contrast media, and it may cause kidney toxicity especially in the patients with underlying kidney disease and decreased kidney function. The investigators intended to find out which contrast agent has less kidney toxicity in the catheter based treatment of coronary arterial diseases in patients with underlying decreased kidney function

Detailed Description

Iodixanol, a nonionic, dimeric, iso-osmolar contrast medium (IOCM), may be less nephrotoxic than nonionic, monomeric, low-osmolar contrast media (LOCMs) in high-risk patients. We compared the nephrotoxicity of iodixanol with that of iopromide, an nonionic, monomeric LOCM, in patients with renal impairment.

Study Timeline

• Study First Submitted: 2009-01-14
• Study First Submitted QC: 2009-01-14
• Study First Posted: 2009-01-15
• Study Start: 2009-02
• Status Verified: 2009-04
• Primary Completion: 2010-05
• Study Completion: 2010-06
• Last Update Submitted: 2010-07-06
• Last Update Posted: 2010-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

• patients who undergo coronary catheterization
• creatinine clearance rates ≤ 60 mL/min using the Cockcroft-Gault formula

Exclusion Criteria

• pregnancy or lactation
• having received contrast media within 7 days of study entry
• emergent coronary angiography
• acute renal failure or end-stage renal disease requiring dialysis
• history of hypersensitivity reaction to contrast media
• unstable hemodynamic states such as cardiogenic shock, pulmonary edema or needing mechanical ventilation
• multiple myeloma
• parenteral use of diuretics
• use of N-acetylcysteine
• use of metformin or nonsteroidal anti-inflammatory drugs within 48 hours of the procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iopromide	contrast agent (iopromide)	-
iodixanol	contrast agent (iodixanol)	-

Primary Outcome Measures

Name	Time	Method
Incidence of contrast induced nephropathy, defined as either a relative increase in serum creatinine from baseline of >=25% or an absolute increase of >=0.5mg/dL(44.2µmol/L)	days 1 and 2

Secondary Outcome Measures

Name	Time	Method
proportion of patients exhibiting an increase in serum creatinine of >=0.5mg/dL(44.2µmol/L), the proportion with a >=1.0 mg/dL(88.4µmol/L) increase in serum creatinine, and the mean peak increase in serum creatinine	days 1 and 2

Trial Locations

Locations (1)

Cardiovascular Center, Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of