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A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients (DIRECT)

Primary Purpose

Kidney Failure, Chronic

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Iopromide (Ultravist)
Iodixanol (Visipaque)
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Failure, Chronic focused on measuring Contrast Induced Nephropathy, CIN, Cardiac Catheterization

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years old or older
  • Plan to undergo Cardiac Catheterization
  • Signed ICF
  • eGFR: 30~59 mL/min/1.73m2

Exclusion Criteria:

  • Pregnancy
  • Under dialysis
  • Conditions interfering with Cardiac Catheterization
  • Participation in other trials
  • Allergic to X-ray contrast media
  • Administration of any investigational drug within the previous 30 days
  • Intra-arterial or intravenous administration of iodinated contrast medium from 7 days before to 72 hours after the administration of study drug
  • Left ventricular ejection fraction (LVEF) less than 30% by ultrasound examination
  • Intake of any nephrotoxic medications 24 hours before or after the administration of study drug

Sites / Locations

  • Beijing CHAO-YANG Hospital
  • General Hospital of Armed Police Forces
  • Peking University Third Hospital
  • Beijing Shi Jing Shan Hospital
  • Beijing Hospital
  • Chinese PLA general hospital
  • Henan Provincial People's Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • Wuhan Asia Heart Hospital
  • The Second Hospital of Xiangya
  • China-Japan Union Hospital of Jilin University
  • The First Hospital of Jilin University
  • Shanghai First People's Hospital
  • Renji Hospital affiliated to Shanghai Jiao Tong University
  • Changhai Hospital affiliated to the second millitary medical university
  • Tianjin Chest Hospital
  • Teda International Cardiovascular Hospital
  • The Second Hospital Affiliated to Zhejiang University
  • Sir Run Run Shaw Hospital affiliated to Zhejiang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Iopromide

Iodixanol

Arm Description

Drug: Ultravist 370 mgl/ml, injection of intra-artery during cardiac interventional operation

Drug: Visipaque 320 mgl/ml, injection of intra-artery

Outcomes

Primary Outcome Measures

Proportion of patients exhibiting a relative increase in serum creatinine >= 50% from baseline.

Secondary Outcome Measures

Proportion of patients developing acute renal failure.
Incidence of a postdose SCr increase ≧25%, a postdose SCr increase ≧1mg/dL, a postdose SCr increase ≧0.5mg/dL, a postdose eGFR decrease ≧25%

Full Information

First Posted
June 19, 2009
Last Updated
June 24, 2011
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00926562
Brief Title
A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients
Acronym
DIRECT
Official Title
A Randomized, Double-blinded Comparison of Iopromide and Iodixanol in Renally Impaired Patients Undergoing Cardiac Catheterization
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators intend to find out which contrast agent has less kidney toxicity in renal impaired patients undergoing cardiac angiography or percutaneous coronary intervention (PCI).
Detailed Description
In the diagnosis and treatment of coronary heart disease, patients should undergo cardiac angiography or percutaneous coronary intervention (PCI). In those procedures, the investigators should use the contrast media, and it may cause kidney toxicity especially in the patients with chronic renal insufficiency.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic
Keywords
Contrast Induced Nephropathy, CIN, Cardiac Catheterization

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
592 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Iopromide
Arm Type
Experimental
Arm Description
Drug: Ultravist 370 mgl/ml, injection of intra-artery during cardiac interventional operation
Arm Title
Iodixanol
Arm Type
Active Comparator
Arm Description
Drug: Visipaque 320 mgl/ml, injection of intra-artery
Intervention Type
Drug
Intervention Name(s)
Iopromide (Ultravist)
Other Intervention Name(s)
Ultravist
Intervention Description
Iopromide (contrast agent), 370 mgl/ml, an nonionic, monomeric, LOCM
Intervention Type
Drug
Intervention Name(s)
Iodixanol (Visipaque)
Other Intervention Name(s)
Visipaque
Intervention Description
Iodixanol (contrast agent) 320 mgl/ml, a nonionic, dimeric, IOCM
Primary Outcome Measure Information:
Title
Proportion of patients exhibiting a relative increase in serum creatinine >= 50% from baseline.
Time Frame
day 3 postreatment
Secondary Outcome Measure Information:
Title
Proportion of patients developing acute renal failure.
Time Frame
day 30 postreatment
Title
Incidence of a postdose SCr increase ≧25%, a postdose SCr increase ≧1mg/dL, a postdose SCr increase ≧0.5mg/dL, a postdose eGFR decrease ≧25%
Time Frame
days 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years old or older Plan to undergo Cardiac Catheterization Signed ICF eGFR: 30~59 mL/min/1.73m2 Exclusion Criteria: Pregnancy Under dialysis Conditions interfering with Cardiac Catheterization Participation in other trials Allergic to X-ray contrast media Administration of any investigational drug within the previous 30 days Intra-arterial or intravenous administration of iodinated contrast medium from 7 days before to 72 hours after the administration of study drug Left ventricular ejection fraction (LVEF) less than 30% by ultrasound examination Intake of any nephrotoxic medications 24 hours before or after the administration of study drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yundai Chen, MD
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing CHAO-YANG Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
General Hospital of Armed Police Forces
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Beijing Shi Jing Shan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
10040
Country
China
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Chinese PLA general hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Wuhan Asia Heart Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
The Second Hospital of Xiangya
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
China-Japan Union Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130033
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jinlin
ZIP/Postal Code
130021
Country
China
Facility Name
Shanghai First People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
Renji Hospital affiliated to Shanghai Jiao Tong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
Changhai Hospital affiliated to the second millitary medical university
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Tianjin Chest Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300051
Country
China
Facility Name
Teda International Cardiovascular Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300457
Country
China
Facility Name
The Second Hospital Affiliated to Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Sir Run Run Shaw Hospital affiliated to Zhejiang
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
23045301
Citation
Chen Y, Hu S, Liu Y, Zhao R, Wang L, Fu G, He Q, Su X, Zheng Y, Qi X, Liu H, Wang J, Gao W, Wang M, Liu S, Zheng X, He B, Yang P, Zhou S, Gao C, Qiu C. Renal tolerability of iopromide and iodixanol in 562 renally impaired patients undergoing cardiac catheterisation: the DIRECT study. EuroIntervention. 2012 Nov 22;8(7):830-8. doi: 10.4244/EIJV8I7A126.
Results Reference
derived

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A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients

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