We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00700375
First Posted: June 18, 2008
Last Update Posted: July 20, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Osaka General Medical Center
June 16, 2008
June 18, 2008
March 23, 2010
July 9, 2010
July 20, 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 ]
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 ]
Complete list of historical versions of study NCT00700375 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
  • 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
  • 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.
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00700375
SBECP
Yes
Not Provided
Not Provided
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