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Effect of Hydration With Sodium Bicarbonate for Long-Term Clinical Outcomes in Patients With Chronic Kidney Disease Undergoing an Emergent Coronary Procedure

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2008 by Osaka General Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00716001
First Posted: July 15, 2008
Last Update Posted: July 15, 2008
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
July 2, 2008
July 15, 2008
July 15, 2008
July 2008
June 2009   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
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Effect of Hydration With Sodium Bicarbonate for Long-Term Clinical Outcomes in Patients With Chronic Kidney Disease Undergoing an Emergent Coronary Procedure
Not Provided
This study is to evaluate the efficacy of sodium bicarbonate plus N-acetylcysteine for the prevention of contrast-induced nephropathy.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Chronic Renal Failure
Drug: N-acetylcysteine
  • Active Comparator: NAC
    Intervention: Drug: N-acetylcysteine
  • Placebo Comparator: nonNAC
    Intervention: Drug: N-acetylcysteine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
Not Provided
Not Provided
June 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients with chronic renal failure(serum creatinine >1.1mg/dl) undergoing elective percutaneous coronary intervention

Exclusion Criteria:

  • administered with sodium bicarbonate and/or N-acetylcysteine and/or contrast media within 72 hours.
  • pregnancy
  • congestive heart failure
  • allergy to sodium bicarbonate and/or N-acetylcysteine
  • hemodialysis
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00716001
OPTSB
No
Not Provided
Not Provided
Masaharu Masuda, Osaka General Medical Center
Osaka General Medical Center
Not Provided
Not Provided
Osaka General Medical Center
July 2008

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