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Contrast-medium Induced Nephrotoxicity in Patients Undergoing Coronary Angiography - Iodixanol Versus Iopromide

Primary Purpose

Chronic Renal Insufficiency, Coronary Angiography

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
contrast agent (iopromide)
contrast agent (iodixanol)
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Renal Insufficiency

Eligibility Criteria

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

Inclusion Criteria:

  • patients who undergo coronary catheterization
  • creatinine clearance rates ≤ 60 mL/min using the Cockcroft-Gault formula

Exclusion Criteria:

  • pregnancy or lactation
  • having received contrast media within 7 days of study entry
  • emergent coronary angiography
  • acute renal failure or end-stage renal disease requiring dialysis
  • history of hypersensitivity reaction to contrast media
  • unstable hemodynamic states such as cardiogenic shock, pulmonary edema or needing mechanical ventilation
  • multiple myeloma
  • parenteral use of diuretics
  • use of N-acetylcysteine
  • use of metformin or nonsteroidal anti-inflammatory drugs within 48 hours of the procedure

Sites / Locations

  • Cardiovascular Center, Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

iopromide

iodixanol

Arm Description

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)

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

First Posted
January 14, 2009
Last Updated
July 6, 2010
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00823628
Brief Title
Contrast-medium Induced Nephrotoxicity in Patients Undergoing Coronary Angiography - Iodixanol Versus Iopromide
Official Title
Comparison of Contrast-medium Induced Nephrotoxicity Between Iodixanol and Iopromide in Patients With Renal Insufficiency Undergoing Coronary Angiography
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
No

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, the investigators should use the contrast media, and it may cause kidney toxicity especially in the patients with underlying kidney disease and decreased kidney function. The investigators 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 iopromide, an nonionic, monomeric 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
Chronic Renal Insufficiency, Coronary Angiography

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iopromide
Arm Type
Active Comparator
Arm Title
iodixanol
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
contrast agent (iopromide)
Intervention Description
coronary angiography using the allocated contrast agent
Intervention Type
Drug
Intervention Name(s)
contrast agent (iodixanol)
Intervention Description
coronary angiography using the allocated contrast agent
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)
Time Frame
days 1 and 2
Secondary Outcome Measure Information:
Title
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
Time Frame
days 1 and 2

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients who undergo coronary catheterization creatinine clearance rates ≤ 60 mL/min using the Cockcroft-Gault formula Exclusion Criteria: pregnancy or lactation having received contrast media within 7 days of study entry emergent coronary angiography acute renal failure or end-stage renal disease requiring dialysis history of hypersensitivity reaction to contrast media unstable hemodynamic states such as cardiogenic shock, pulmonary edema or needing mechanical ventilation multiple myeloma parenteral use of diuretics use of N-acetylcysteine use of metformin or nonsteroidal anti-inflammatory drugs within 48 hours of the procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tae-Jin Youn, MD, PhD
Organizational Affiliation
Facility: Cardiovascular Center, Seoul National University Bundang Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Cardiovascular Center, Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

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Contrast-medium Induced Nephrotoxicity in Patients Undergoing Coronary Angiography - Iodixanol Versus Iopromide

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