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
Information provided by:
Osaka General Medical Center
ClinicalTrials.gov Identifier:
First received: July 2, 2008
Last updated: July 11, 2008
Last verified: July 2008
This study is to evaluate the efficacy of sodium bicarbonate plus N-acetylcysteine for the prevention of contrast-induced nephropathy.

Condition Intervention Phase
Chronic Renal Failure
Drug: N-acetylcysteine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label

Resource links provided by NLM:

Further study details as provided by Osaka General Medical Center:

Study Start Date: July 2008
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NAC Drug: N-acetylcysteine
Placebo Comparator: nonNAC Drug: N-acetylcysteine


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Responsible Party: Masaharu Masuda, Osaka General Medical Center
ClinicalTrials.gov Identifier: NCT00716001     History of Changes
Other Study ID Numbers: OPTSB 
Study First Received: July 2, 2008
Last Updated: July 11, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Osaka General Medical Center:
patients with chronic renal failure undergoing elective percutaneous coronary intervention

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Anti-Infective Agents
Antiviral Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 26, 2016