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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by CardioVascular Research Foundation, Korea.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00950079
First Posted: July 31, 2009
Last Update Posted: July 31, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
CardioVascular Research Foundation, Korea
  Purpose
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.

Condition Intervention Phase
Contrast Induced Nephropathy Drug: Sodium bicarbonate Drug: saline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Preventive Strategies of REnal Insufficiency in Patients With Diabetes Undergoing InterVENTion or Arteriography(PREVENT Trial)

Resource links provided by NLM:


Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:
  • Incidence of contrast-induced nephropathy [ Time Frame: 24 and 48 hours after angiography or intervention ]

Secondary Outcome Measures:
  • all-cause mortality [ Time Frame: 30 days after index angiography ]
  • stroke [ Time Frame: 30 days after index angiography ]
  • Dialysis [ Time Frame: 30 days after index angiography ]
  • Myocardial infarction [ Time Frame: 30 days after index angiography ]
  • all-cause mortality [ Time Frame: 30 days to 6 months after index angiography ]
  • stroke [ Time Frame: 30 days to 6 months after index angiography ]
  • dialysis [ Time Frame: 30 days to 6 months after index angiography ]
  • myocardial infarction [ Time Frame: 30 days to 6 months after index angiography ]

Estimated Enrollment: 368
Study Start Date: February 2008
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00950079


Contacts
Contact: Seong-Wook Park, MD, PhD 2-3010-3153 ext 82 swpark@amc.seoul.kr
Contact: Seung-Whan Lee, MD, PhD 2-3010-3170 ext 82 seungwlee@amc.seoul.kr

Locations
Korea, Republic of
Soonchunhyang University Bucheon Hospital Recruiting
Bucheon, Korea, Republic of
Contact: Nae-Hee Lee, MD, PhD         
Principal Investigator: Nae-Hee Lee, MD, PhD         
Busan Saint Mary Hospital Recruiting
Busan, Korea, Republic of
Contact: Jae-Sik Jang, MD         
Principal Investigator: Jae-Sik Jang, MD         
Soonchunhyang University Hospital, Cheonan Recruiting
Cheonan, Korea, Republic of
Contact: Won-Yong Shin, MD, PhD         
Principal Investigator: Dong-Gyu Jin, MD, PhD         
Kangwon National University Hospital Recruiting
Chuncheon, Korea, Republic of
Contact: Bong-Ki Lee, MD, PhD         
Contact: Bong-Ki Lee         
Principal Investigator: Bong-Ki Lee, MD, PhD         
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of
Contact: In-Whan Seong, MD, PhD         
Principal Investigator: In-Whan Seong, MD, PhD         
Gangneung Asan Hospital Recruiting
Gangneung, Korea, Republic of
Contact: Sang-Sik Cheong         
Principal Investigator: Sang-Sik Cheong, MD, PhD         
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Seong-Wook Park, MD, PhD    2-3010-3153 ext 82    swpark@amc.seoul.kr   
Contact: Seung-Whan Lee, MD, PhD    2-3010-3170 ext 82    seungwlee@amc.seoul.kr   
Principal Investigator: Seong-Wook Park, MD, PhD         
Soonchunhyang University Seoul Hospital Recruiting
Seoul, Korea, Republic of
Contact: Min-Su Hyun, MD, PhD         
Principal Investigator: Min-Su Hyun, MD, PhD         
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of
Contact: Sang-Gon Lee, MD, PhD         
Principal Investigator: Sang-Gon Lee, MD, PhD         
Sponsors and Collaborators
CardioVascular Research Foundation, Korea
Investigators
Principal Investigator: Seong-Wook Park, MD, PhD Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
  More Information

Responsible Party: Seong-Wook Park, MD, PhD, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00950079     History of Changes
Other Study ID Numbers: 2007-0180
First Submitted: July 6, 2009
First Posted: July 31, 2009
Last Update Posted: July 31, 2009
Last Verified: July 2009

Keywords provided by CardioVascular Research Foundation, Korea:
sodium bicarbonate
diabetes mellitus
coronary angiography or intervention

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases