Prevention of Contrast-Induced Nephropathy in Diabetic Patients With Undergoing Coronary Angiography
- Registration Number
- NCT00950079
- Lead Sponsor
- CardioVascular Research Foundation, Korea
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 368
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Saline saline saline infusion Sodium bicarbonate Sodium bicarbonate sodium bicarbonate
- Primary Outcome Measures
Name Time Method Incidence of contrast-induced nephropathy 24 and 48 hours after angiography or intervention
- Secondary Outcome Measures
Name Time Method all-cause mortality 30 days to 6 months after index angiography stroke 30 days to 6 months after index angiography Dialysis 30 days after index angiography Myocardial infarction 30 days after index angiography dialysis 30 days to 6 months after index angiography myocardial infarction 30 days to 6 months after index angiography
Trial Locations
- Locations (9)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Busan Saint Mary Hospital
🇰🇷Busan, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Soonchunhyang University Bucheon Hospital
🇰🇷Bucheon, Korea, Republic of
Soonchunhyang University Hospital, Cheonan
🇰🇷Cheonan, Korea, Republic of
Kangwon National University Hospital
🇰🇷Chuncheon, Korea, Republic of
Soonchunhyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Gangneung Asan Hospital
🇰🇷Gangneung, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of