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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by CardioVascular Research Foundation, Korea.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT00950079
First received: July 6, 2009
Last updated: July 30, 2009
Last verified: July 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]

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

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
Other Name: Sodium bicarbonate
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
Other Name: saline

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Seong-Wook Park, MD, PhD, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00950079     History of Changes
Other Study ID Numbers: 2007-0180
Study First Received: July 6, 2009
Last Updated: July 30, 2009
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 19, 2014