RECOVER:Comparison of Renal Toxicity Between Visipaque(Iodixanol)and Hexabrix(Ioxaglate)in Renal Insufficiency Undergoing Coronary Angiography

Phase 4

Completed

• Conditions: Kidney Failure

• Registration Number: NCT00247325
• Lead Sponsor: Seoul National University 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, we should use the contrast media, and it may cause kidney toxicity especially in the patients with underlying kidney disease and decreased kidney function. We 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 ioxaglate, an ionic, dimeric LOCM, in patients with renal impairment.

Study Timeline

• Study Start: 2004-01
• Study Completion: 2004-12
• Status Verified: 2005-01
• Study First Submitted: 2005-10-31
• Study First Submitted QC: 2005-10-31
• Study First Posted: 2005-11-01
• Last Update Submitted: 2006-11-29
• Last Update Posted: 2006-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• creatinine clearance rates ≤60 mL/min using the Cockcroft-Gault formula
• Patients who undergo coronary catheterization
• Age of 19 or over 19.

Exclusion Criteria

• pregnancy
• lactation
• having received contrast media within 7 days of study entry
• emergent coronary angiography
• acute renal failure
• end-stage renal disease requiring dialysis
• history of hypersensitivity reaction to contrast media
• cardiogenic shock
• pulmonary edema
• multiple myeloma
• mechanical ventilation
• 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

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) during 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

Trial Locations

Locations (1)

Seoul National University Hospital , Cardiovascular Center; 🇰🇷 Seoul, Korea, Republic of