Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection

Osaka General Medical Center59 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Emergent Coronary Procedure

Interventions

Sodium bicarbonateDRUG

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

Sodium ChlorideDRUG

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

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (1)

Osaka General Medical Center

Osaka, Japan

Outcomes

Primary Outcomes

Occurrence of Contrast-induced Nephropathy

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.

Time frame: after procedure and 1,2-3day after procedure

Data from ClinicalTrials.gov

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