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Prevention of Contrast-Induced Nephropathy in Diabetic Patients With Undergoing Coronary Angiography

Primary Purpose

Contrast Induced Nephropathy

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sodium bicarbonate
saline
Sponsored by
CardioVascular Research Foundation, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Contrast Induced Nephropathy focused on measuring sodium bicarbonate, diabetes mellitus, coronary angiography or intervention

Eligibility Criteria

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

Inclusion Criteria:

  • age>18 years, no upper limits
  • diabetes treated with insulin or oral hypoglycemic agents
  • serum creatinine >=1.1 and
  • resting estimated glomerular filtration rate <60ml/min/1.73 square meter

Exclusion Criteria:

  • serum creatinine >=8mg/dL
  • resting estimated GFR <15ml/min/1.73 square meter
  • end stage renal disease on hemodialysis
  • multiple myeloma
  • uncontrolled hypertension (systolic BP >160mmHg or diastolic BP>100mmHg)
  • acute myocardial infarction
  • emergent coronary angioplasty or angiography
  • recent use of contrast within 2 days
  • allergic reaction to contrast
  • pregnancy
  • allergic to following medication : theophylline, dopamine, mannitol, fenoldopam, N-acetylcysteine

Sites / Locations

  • Soonchunhyang University Bucheon HospitalRecruiting
  • Busan Saint Mary HospitalRecruiting
  • Soonchunhyang University Hospital, CheonanRecruiting
  • Kangwon National University HospitalRecruiting
  • Chungnam National University HospitalRecruiting
  • Gangneung Asan HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Soonchunhyang University Seoul HospitalRecruiting
  • Ulsan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sodium bicarbonate

Saline

Arm Description

sodium bicarbonate

saline infusion

Outcomes

Primary Outcome Measures

Incidence of contrast-induced nephropathy

Secondary Outcome Measures

all-cause mortality
stroke
Dialysis
Myocardial infarction
all-cause mortality
stroke
dialysis
myocardial infarction

Full Information

First Posted
July 6, 2009
Last Updated
July 30, 2009
Sponsor
CardioVascular Research Foundation, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT00950079
Brief Title
Prevention of Contrast-Induced Nephropathy in Diabetic Patients With Undergoing Coronary Angiography
Official Title
Preventive Strategies of REnal Insufficiency in Patients With Diabetes Undergoing InterVENTion or Arteriography(PREVENT Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
August 2009 (Anticipated)
Study Completion Date
January 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
CardioVascular Research Foundation, Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to determine whether sodium bicarbonate is superior to sodium chloride in preventing contrast induced nephropathy in diabetic patients undergoing coronary angiography or intervention.
Detailed Description
Contrast induced nephropathy (CIN) is a common cause of renal failure associated with prolonged hospitalization, significant morbidity or mortality, and cost. CIN has been reported to account for 10% of hospital acquired renal failure. Several strategies or medications were tried to prevent CIN. Of these, mucomyst and normal saline infusion are effective to prevent CIN. Sodium bicarbonate has shown mixed results from recent randomized trials. Moreover,limited data have been available for preventing CIN in diabetic renal dysfunction undergoing coronary angiography or intervention. Our hypothesis is that addition of sodium bicarbonate will be more efficacious than normal saline in preventing CIN at above situation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast Induced Nephropathy
Keywords
sodium bicarbonate, diabetes mellitus, coronary angiography or intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
368 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sodium bicarbonate
Arm Type
Experimental
Arm Description
sodium bicarbonate
Arm Title
Saline
Arm Type
Active Comparator
Arm Description
saline infusion
Intervention Type
Drug
Intervention Name(s)
Sodium bicarbonate
Intervention Description
3 mL/kg for 1 hour immediately before contrast injection , 1mg/kg/hr during procedure and 6 hours after procedure
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
0.9% normal saline with 1 mL/kg/hr infusion 12 hours before procedure and 12 hours after procedure
Primary Outcome Measure Information:
Title
Incidence of contrast-induced nephropathy
Time Frame
24 and 48 hours after angiography or intervention
Secondary Outcome Measure Information:
Title
all-cause mortality
Time Frame
30 days after index angiography
Title
stroke
Time Frame
30 days after index angiography
Title
Dialysis
Time Frame
30 days after index angiography
Title
Myocardial infarction
Time Frame
30 days after index angiography
Title
all-cause mortality
Time Frame
30 days to 6 months after index angiography
Title
stroke
Time Frame
30 days to 6 months after index angiography
Title
dialysis
Time Frame
30 days to 6 months after index angiography
Title
myocardial infarction
Time Frame
30 days to 6 months after index angiography

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age>18 years, no upper limits diabetes treated with insulin or oral hypoglycemic agents serum creatinine >=1.1 and resting estimated glomerular filtration rate <60ml/min/1.73 square meter Exclusion Criteria: serum creatinine >=8mg/dL resting estimated GFR <15ml/min/1.73 square meter end stage renal disease on hemodialysis multiple myeloma uncontrolled hypertension (systolic BP >160mmHg or diastolic BP>100mmHg) acute myocardial infarction emergent coronary angioplasty or angiography recent use of contrast within 2 days allergic reaction to contrast pregnancy allergic to following medication : theophylline, dopamine, mannitol, fenoldopam, N-acetylcysteine
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seong-Wook Park, MD, PhD
Phone
2-3010-3153
Ext
82
Email
swpark@amc.seoul.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Seung-Whan Lee, MD, PhD
Phone
2-3010-3170
Ext
82
Email
seungwlee@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seong-Wook Park, MD, PhD
Organizational Affiliation
Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soonchunhyang University Bucheon Hospital
City
Bucheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nae-Hee Lee, MD, PhD
First Name & Middle Initial & Last Name & Degree
Nae-Hee Lee, MD, PhD
Facility Name
Busan Saint Mary Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Sik Jang, MD
First Name & Middle Initial & Last Name & Degree
Jae-Sik Jang, MD
Facility Name
Soonchunhyang University Hospital, Cheonan
City
Cheonan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Won-Yong Shin, MD, PhD
First Name & Middle Initial & Last Name & Degree
Dong-Gyu Jin, MD, PhD
Facility Name
Kangwon National University Hospital
City
Chuncheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bong-Ki Lee, MD, PhD
First Name & Middle Initial & Last Name & Degree
Bong-Ki Lee
First Name & Middle Initial & Last Name & Degree
Bong-Ki Lee, MD, PhD
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
In-Whan Seong, MD, PhD
First Name & Middle Initial & Last Name & Degree
In-Whan Seong, MD, PhD
Facility Name
Gangneung Asan Hospital
City
Gangneung
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang-Sik Cheong
First Name & Middle Initial & Last Name & Degree
Sang-Sik Cheong, MD, PhD
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seong-Wook Park, MD, PhD
Phone
2-3010-3153
Ext
82
Email
swpark@amc.seoul.kr
First Name & Middle Initial & Last Name & Degree
Seung-Whan Lee, MD, PhD
Phone
2-3010-3170
Ext
82
Email
seungwlee@amc.seoul.kr
First Name & Middle Initial & Last Name & Degree
Seong-Wook Park, MD, PhD
Facility Name
Soonchunhyang University Seoul Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min-Su Hyun, MD, PhD
First Name & Middle Initial & Last Name & Degree
Min-Su Hyun, MD, PhD
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang-Gon Lee, MD, PhD
First Name & Middle Initial & Last Name & Degree
Sang-Gon Lee, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Prevention of Contrast-Induced Nephropathy in Diabetic Patients With Undergoing Coronary Angiography

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