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

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00247325
First received: October 31, 2005
Last updated: November 29, 2006
Last verified: January 2005
  Purpose

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


Condition Intervention Phase
Kidney Failure
Drug: Iodixanol(Drug)
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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:
  • 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

Study Start Date: January 2004
Estimated Study Completion Date: December 2004
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00247325

Locations
Korea, Republic of
Seoul National University Hospital , Cardiovascular Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Director: Hyo-Soo Kim, M.D., Ph.D. Seoul National University Hospital, Cardiovascular Center
Study Chair: Byung-Hee Oh, M.D., Ph.D. Seoul National University Hospital, Internal Medicine/ Cardiovascular Center
Principal Investigator: Sang-Ho Jo, M.D. Seoul National University Hospital, Cardiovascular Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00247325     History of Changes
Other Study ID Numbers: 144-가-24, 144-가-24
Study First Received: October 31, 2005
Last Updated: November 29, 2006
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Hospital:
Kidney failure
Contrast media
Iodixanol
Ioxaglate

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 24, 2014