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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium bicarbonate | Experimental | sodium bicarbonate |
|
| Saline | Active Comparator | saline infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium bicarbonate | Drug | 3 mL/kg for 1 hour immediately before contrast injection , 1mg/kg/hr during procedure and 6 hours after procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of contrast-induced nephropathy | 24 and 48 hours after angiography or intervention |
| Measure | Description | Time Frame |
|---|---|---|
| all-cause mortality | 30 days after index angiography | |
| stroke | 30 days after index angiography | |
| Dialysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seong-Wook Park, MD, PhD | Contact | 2-3010-3153 | 82 | swpark@amc.seoul.kr |
| Seung-Whan Lee, MD, PhD | Contact | 2-3010-3170 | 82 | seungwlee@amc.seoul.kr |
| Name | Affiliation | Role |
|---|---|---|
| Seong-Wook Park, MD, PhD | Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soonchunhyang University Bucheon Hospital | Recruiting | Bucheon-si | South Korea |
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| saline | Drug | 0.9% normal saline with 1 mL/kg/hr infusion 12 hours before procedure and 12 hours after procedure |
|
| 30 days after index angiography |
| Myocardial infarction | 30 days after index angiography |
| all-cause mortality | 30 days to 6 months after index angiography |
| stroke | 30 days to 6 months after index angiography |
| dialysis | 30 days to 6 months after index angiography |
| myocardial infarction | 30 days to 6 months after index angiography |
| Busan Saint Mary Hospital | Recruiting | Busan | South Korea |
|
| Soonchunhyang University Hospital, Cheonan | Recruiting | Cheonan | South Korea |
|
| Kangwon National University Hospital | Recruiting | Chuncheon | South Korea |
|
| Chungnam National University Hospital | Recruiting | Daejeon | South Korea |
|
| Gangneung Asan Hospital | Recruiting | Gangneung | South Korea |
|
| Asan Medical Center | Recruiting | Seoul | 138-736 | South Korea |
|
| Soonchunhyang University Seoul Hospital | Recruiting | Seoul | South Korea |
|
| Ulsan University Hospital | Recruiting | Ulsan | South Korea |
|
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
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