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 because the information has not been verified recently.
Verified July 2008 by Osaka General Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Osaka General Medical Center
ClinicalTrials.gov Identifier:
NCT00716001
First received: July 2, 2008
Last updated: July 11, 2008
Last verified: July 2008

July 2, 2008
July 11, 2008
July 2008
June 2009   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00716001 on ClinicalTrials.gov Archive Site
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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
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This study is to evaluate the efficacy of sodium bicarbonate plus N-acetylcysteine for the prevention of contrast-induced nephropathy.

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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Chronic Renal Failure
Drug: N-acetylcysteine
  • Active Comparator: NAC
    Intervention: Drug: N-acetylcysteine
  • Placebo Comparator: nonNAC
    Intervention: Drug: N-acetylcysteine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
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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
Both
20 Years and older
No
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NCT00716001
OPTSB
No
Masaharu Masuda, Osaka General Medical Center
Osaka General Medical Center
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Osaka General Medical Center
July 2008

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