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 4
  • Study Type

    Interventional
  • Study Participants

    59
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 Started
Jul 31
2008
Primary Completion
Mar 31
2010
Study Completion
Mar 31
2010
Results Posted
Jul 09
2010
Estimate
Last Update
Jul 20
2010
Estimate

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

Drug 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

Sodium bicarbonate Experimental

Sodium chloride Experimental

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.

Summary

Sodium Bicarbonate Group

Sodium Chloride Group

All Events

Event Type Organ System Event Term Sodium Bicarbonate Group Sodium Chloride Group

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.

Sodium Bicarbonate Group

1.0
participants

Sodium Chloride Group

8.0
participants

Total

59
Participants

Age Continuous

75
years (Mean)
Standard Deviation: 9.8

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

Sodium Bicarbonate Group

Sodium Chloride Group