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

Primary Purpose

Kidney Failure

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Iodixanol(Drug)

About this trial

This is an interventional prevention trial for Kidney Failure focused on measuring Kidney failure, Contrast media, Iodixanol, Ioxaglate

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Seoul National University Hospital , Cardiovascular Center

Outcomes

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

Full Information

NCT ID

NCT00247325

First Posted

October 31, 2005

Last Updated

November 29, 2006

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00247325

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2005

Overall Recruitment Status

Completed

Study Start Date

January 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Seoul National University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Failure

Keywords

Kidney failure, Contrast media, Iodixanol, Ioxaglate

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Single

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Iodixanol(Drug)

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hyo-Soo Kim, M.D., Ph.D.

Organizational Affiliation

Seoul National University Hospital, Cardiovascular Center

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Byung-Hee Oh, M.D., Ph.D.

Organizational Affiliation

Seoul National University Hospital, Internal Medicine/ Cardiovascular Center

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Sang-Ho Jo, M.D.

Organizational Affiliation

Seoul National University Hospital, Cardiovascular Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital , Cardiovascular Center

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

16949481

Citation

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 undergoing coronary angiography: the RECOVER study: a randomized controlled trial. J Am Coll Cardiol. 2006 Sep 5;48(5):924-30. doi: 10.1016/j.jacc.2006.06.047. Epub 2006 Aug 17.

Results Reference

result

Learn more about this trial

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

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