Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection

Phase 4

Completed

• Conditions: Emergent Coronary Procedure
• Interventions: Drug: Sodium bicarbonate; Drug: Sodium Chloride

• Registration Number: NCT00700375
• Lead Sponsor: Osaka General Medical Center

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2008-06-16
• Study First Submitted QC: 2008-06-17
• Study First Posted: 2008-06-18
• Study Start: 2008-07
• Status Verified: 2010-03
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Results First Submitted: 2010-03-23
• Results First Submitted QC: 2010-06-14
• Results First Posted: 2010-07-09
• Last Update Submitted: 2010-07-12
• Last Update Posted: 2010-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium bicarbonate	Sodium bicarbonate	-
Sodium chloride	Sodium Chloride	-

Primary Outcome Measures

Name	Time	Method
Occurrence of Contrast-induced Nephropathy	after procedure and 1,2-3day after procedure	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.

Trial Locations

Locations (1)

Osaka General Medical Center; 🇯🇵 Osaka, Japan