Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection

This study has been completed.
Sponsor:
Information provided by:
Osaka General Medical Center
ClinicalTrials.gov Identifier:
NCT00700375
First received: June 16, 2008
Last updated: July 12, 2010
Last verified: March 2010

June 16, 2008
July 12, 2010
July 2008
March 2010   (final data collection date for primary outcome measure)
Occurrence of Contrast-induced Nephropathy [ Time Frame: after procedure and 1,2-3day after procedure ] [ Designated as safety issue: No ]
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.
measurement of serum creatinine level [ Time Frame: after procedure and 1,2-3day after procedure ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00700375 on ClinicalTrials.gov Archive Site
Not Provided
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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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Emergent Coronary Procedure
  • 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
    Other Name: Sodium bicarbonate
  • 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
    Other Name: Sodium chloride
  • Experimental: Sodium bicarbonate
    Intervention: Drug: Sodium bicarbonate
  • Experimental: Sodium chloride
    Intervention: Drug: Sodium Chloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
March 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00700375
SBECP
Yes
Hiromichi Ueda, Osaka General Medical Center
Osaka General Medical Center
Not Provided
Study Chair: Takahisa Yamada, directorate OsakaGeneralMedicalCenter
Osaka General Medical Center
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP