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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00247325
Enrollment
Unknown
Registered
2005-11-01
Start date
2004-01-31
Completion date
2004-12-31
Last updated
2006-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure

Keywords

Kidney failure, Contrast media, Iodixanol, Ioxaglate

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.

Interventions

DRUGIodixanol(Drug)

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 11, 2026