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Clinical Trials/NCT00700375
NCT00700375
Completed
Phase 4

Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection in Patients Undergoing an Emergent Coronary Procedure

Osaka General Medical Center1 site in 1 country59 target enrollmentJuly 2008

Overview

Phase
Phase 4
Intervention
Sodium bicarbonate
Conditions
Emergent Coronary Procedure
Sponsor
Osaka General Medical Center
Enrollment
59
Locations
1
Primary Endpoint
Occurrence of Contrast-induced Nephropathy
Status
Completed
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2008
End Date
March 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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.

Arms & Interventions

Sodium bicarbonate

Intervention: Sodium bicarbonate

Sodium chloride

Intervention: Sodium Chloride

Outcomes

Primary Outcomes

Occurrence of Contrast-induced Nephropathy

Time Frame: 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.

Study Sites (1)

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