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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:
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
  Purpose
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
Intervention Model: Parallel Assignment
Masking: None (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

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on August 23, 2017