Title
Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection
Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection in Patients Undergoing an Emergent Coronary Procedure
Phase
Phase 4Lead Sponsor
Osaka General Medical CenterStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Emergent Coronary ProcedureIntervention/Treatment
sodium bicarbonate sodium chloride ...Study Participants
59This study is to investigate the effect of Sodium Bicarbonate bolus injection in patients undergoing an emergent coronary procedure for prevention of contrast-induced nephropathy.
This study is to investigate the effect of Sodium Bicarbonate bolus injection in patients undergoing an emergent coronary procedure for prevention of contrast-induced nephropathy.The End point is development of contrast-induced nephropathy.
8.4%sodium bicarbonate 0.5ml/kg bolus injection before procedure and hydration with 154mEq/l sodium bicarbonate 1ml/kg/Hr for 6 hours after the procedure
8.4%sodium bicarbonate 0.5ml/kg bolus injection before procedure and hydration with 154mEq/l sodium bicarbonate 1ml/kg/Hr for 6 hours after the procedure
Inclusion Criteria: Patients undergoing an emergent coronary procedure(within 60 minutes from admission) Exclusion Criteria: On dialysis Pregnancy Past use of bicarbonate or N-Acetyl-Cystein in 48hr Past exposure to contrast media in 48hr Circulatory insufficiency with lactic acidosis.
Event Type | Organ System | Event Term | Sodium Bicarbonate Group | Sodium Chloride Group |
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The primary endpoint was the occurrence of contrast-induced nephropathy, defined as an increase >0.5 mg/dl or >25% in serum Cr concentration within 2 days of the procedure compared to the baseline level.