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

Kidney Failure Clinical Trial

Official title:

Renal Toxicity Evaluation and Comparison Between Visipaque (Iodixanol) and Hexabrix (Ioxaglate) in Renal Insufficiency Undergoing Coronary Angiography: The RECOVER Study, A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00247325
• Other study ID #: 144-?-24
• Secondary ID: 144-?-24
• Status: Completed
• Phase: Phase 4
• First received: October 31, 2005
• Last updated: November 29, 2006
• Start date: January 2004
• Est. completion date: December 2004

Study information

• Verified date: January 2005
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Failure
• Renal Insufficiency

Intervention

Drug:
• Iodixanol(Drug)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital , Cardiovascular Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Jo SH, Youn TJ, Koo BK, Park JS, Kang HJ, Cho YS, Chung WY, Joo GW, Chae IH, Choi DJ, Oh BH, Lee MM, Park YB, Kim HS. Renal toxicity evaluation and comparison between visipaque (iodixanol) and hexabrix (ioxaglate) in patients with renal insufficiency unde — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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