Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection

Emergent Coronary Procedure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00700375
• Other study ID #: SBECP
• Status: Completed
• Phase: Phase 4
• First received: June 16, 2008
• Last updated: July 12, 2010
• Start date: July 2008
• Est. completion date: March 2010

Study information

• Verified date: March 2010
• Source: Osaka General Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Emergent Coronary Procedure

Intervention

Drug:
• Sodium bicarbonate
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 Chloride
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

Locations

Country	Name	City	State
Japan	Osaka General Medical Center	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Osaka General Medical Center

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	after procedure and 1,2-3day after procedure	No