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

July 30, 2009 updated by: CardioVascular Research Foundation, Korea

Preventive Strategies of REnal Insufficiency in Patients With Diabetes Undergoing InterVENTion or Arteriography(PREVENT Trial)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

368

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Bucheon, Korea, Republic of
        • Recruiting
        • Soonchunhyang University Bucheon Hospital
        • Contact:
          • Nae-Hee Lee, MD, PhD
        • Principal Investigator:
          • Nae-Hee Lee, MD, PhD
      • Busan, Korea, Republic of
        • Recruiting
        • Busan Saint Mary Hospital
        • Contact:
          • Jae-sik Jang, MD
        • Principal Investigator:
          • Jae-sik Jang, MD
      • Cheonan, Korea, Republic of
        • Recruiting
        • Soonchunhyang University Hospital, Cheonan
        • Contact:
          • Won-Yong Shin, MD, PhD
        • Principal Investigator:
          • Dong-Gyu Jin, MD, PhD
      • Chuncheon, Korea, Republic of
        • Recruiting
        • Kangwon National University Hospital
        • Contact:
          • Bong-Ki Lee, MD, PhD
        • Contact:
          • Bong-Ki Lee
        • Principal Investigator:
          • Bong-Ki Lee, MD, PhD
      • Daejeon, Korea, Republic of
        • Recruiting
        • Chungnam National University Hospital
        • Contact:
          • In-Whan Seong, MD, PhD
        • Principal Investigator:
          • In-Whan Seong, MD, PhD
      • Gangneung, Korea, Republic of
        • Recruiting
        • Gangneung Asan Hospital
        • Contact:
          • Sang-Sik Cheong
        • Principal Investigator:
          • Sang-Sik Cheong, MD, PhD
      • Seoul, Korea, Republic of, 138-736
        • Recruiting
        • Asan Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Seong-Wook Park, MD, PhD
      • Seoul, Korea, Republic of
        • Recruiting
        • Soonchunhyang University Seoul Hospital
        • Contact:
          • Min-Su Hyun, MD, PhD
        • Principal Investigator:
          • Min-Su Hyun, MD, PhD
      • Ulsan, Korea, Republic of
        • Recruiting
        • Ulsan University Hospital
        • Contact:
          • Sang-Gon Lee, MD, PhD
        • Principal Investigator:
          • Sang-Gon Lee, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sodium bicarbonate
sodium bicarbonate
Drug: Sodium bicarbonate
3 mL/kg for 1 hour immediately before contrast injection , 1mg/kg/hr during procedure and 6 hours after procedure
Active Comparator: Saline
saline infusion
Drug: saline
0.9% normal saline with 1 mL/kg/hr infusion 12 hours before procedure and 12 hours after procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of contrast-induced nephropathy
Time Frame: 24 and 48 hours after angiography or intervention
24 and 48 hours after angiography or intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
all-cause mortality
Time Frame: 30 days after index angiography
30 days after index angiography
stroke
Time Frame: 30 days after index angiography
30 days after index angiography
Dialysis
Time Frame: 30 days after index angiography
30 days after index angiography
Myocardial infarction
Time Frame: 30 days after index angiography
30 days after index angiography
all-cause mortality
Time Frame: 30 days to 6 months after index angiography
30 days to 6 months after index angiography
stroke
Time Frame: 30 days to 6 months after index angiography
30 days to 6 months after index angiography
dialysis
Time Frame: 30 days to 6 months after index angiography
30 days to 6 months after index angiography
myocardial infarction
Time Frame: 30 days to 6 months after index angiography
30 days to 6 months after index angiography

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CardioVascular Research Foundation, Korea

Investigators

  • Principal Investigator: Seong-Wook Park, MD, PhD, Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Anticipated)

August 1, 2009

Study Completion (Anticipated)

January 1, 2010

Study Registration Dates

First Submitted

July 6, 2009

First Submitted That Met QC Criteria

July 30, 2009

First Posted (Estimate)

July 31, 2009

Study Record Updates

Last Update Posted (Estimate)

July 31, 2009

Last Update Submitted That Met QC Criteria

July 30, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-0180

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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