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

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. Identifier: NCT00716001
Recruitment Status : Unknown
Verified July 2008 by Osaka General Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 15, 2008
Last Update Posted : July 15, 2008
Information provided by:
Osaka General Medical Center

Brief Summary:
This study is to evaluate the efficacy of sodium bicarbonate plus N-acetylcysteine for the prevention of contrast-induced nephropathy.

Condition or disease Intervention/treatment Phase
Chronic Renal Failure Drug: N-acetylcysteine Phase 4

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Study Start Date : July 2008
Estimated Primary Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: NAC Drug: N-acetylcysteine
Placebo Comparator: nonNAC Drug: N-acetylcysteine

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Responsible Party: Masaharu Masuda, Osaka General Medical Center Identifier: NCT00716001     History of Changes
Other Study ID Numbers: OPTSB
First Posted: July 15, 2008    Key Record Dates
Last Update Posted: July 15, 2008
Last Verified: July 2008

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

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